QA Manager

Ø  Leading Contract Manufacturer

Ø  Exciting Permanent Opportunity

Ø  Fast Paced, Dynamic Working Environment

Sphere Healthcare is a leading contract manufacturer of Complementary Healthcare Products, based in Sydney with easy access to major motorways.

We have the perfect opportunity for an individual looking to work in a challenging role.  The successful candidate will be reporting to the Head of Quality and managing a team of QA officers. The candidate will have superior attention to detail and a demonstrated subject matter expert for manufacturing & packaging processes to comply with local Regulatory standards, while having the flexibility and capacity to operate both autonomously and as a team player, depending on the dynamic challenges of the day.

Key Responsibilities Include:

Ø  Manage Release for Supply of products in line with PIC/S and TGA

Ø  Mange Review of batch documentation and release of batches of Intermediates, Bulk & Finished Products and packaging materials in compliance with all relevant regulatory standards

Ø  Manage, sustain and improve site compliance to regulatory requirements such as TGA, DoAW (NSW Food Authority), HACCP

Ø  Manage Corrective and Preventative Actions system and follow up on CAPA plans

Ø  Investigate and troubleshoot any production incidents

Ø  Manage Customer Compliant System and Process Deviation Systems and liaise with sponsors

Ø  Create, review & / or authorize all relevant process deviations required during batch document review or batch release activities

Ø  Participate in Investigations including Root Cause Analysis & Risk Assessments

Ø  Manage a team of QA officers & report on Quality Key Performance Indicators

Ø  Manage Internal Audit Program in line with approved standard operating procedure

Ø  Manage Product Quality Reviews and liaise with sponsors

Ø  Participate in customer / regulatory / certification audits and close out

Ø  Perform Compliance Trend Analysis as defined in relevant organizational procedures

Ø  Promote and develop innovative solutions to improve QA performance and costs

Skill Requirements Include:

Ø  A tertiary qualification in Science or equivalent, or demonstrated operational experience of at least 5 Years in a pharmaceutical laboratory &/or QA role

Ø  A superior knowledge of and ability to interpret current GMP / GLP requirements within the Complementary Healthcare industry

Ø  Excellent knowledge of latest PIC/S and relevant TGA guidelines

Ø  Excellent attention to detail, the ability to take the initiative within the constraints of regulations and a high work ethic and able to observe WHS standards

Ø  Experience working with SAP will be an advantage

Ø  Excellent written, oral and interpersonal communication skills, effective team player within a challenging environment

Ø  Flexible; able to work in an environment where priorities and deadlines change on a frequent basis

Ø  Excellent computer literacy, including LIMS & Microsoft applications, especially Word & Excel

This is a great opportunity for someone with good experience and attitude to join our hardworking, cohesive and friendly team.  A strong awareness of Chinese culture and language would also be an advantage.

If you feel you have the above experience and skill set, submit your covering letter and resume via Seek.

Only applicant selected for interview will be contacted.

All other applicants are thanked for their interest.

Supervisor / Fitter

Ø  Leading Healthcare Manufacturer

Ø  Exciting Opportunity in Growing Organisation

Ø  Fast Paced, Dynamic Working Environment

Sphere Healthcare is a leading Australian-owned contract manufacturer of Complementary Healthcare Products, based in Sydney with easy access to major motorways.

Our growing company is looking for an energetic, motivated and results driven Supervisor / Fitter to oversee all aspects of our Packaging Department. The ideal candidate should have a “hands on” approach and experience organizing work groups, coaching employees, monitoring progress, enforcing rules and ensuring quality compliance.

The successful applicant must possess mechanical/fitter trade skills, strong communication and leadership skills as well as the ability to resolve workplace issues effectively.

The Role:

Ø  Maintain compliance to the company’s and external quality systems eg GMP, HACCP

Ø  Ensure delivery of the production schedule and departmental KPI’s

Ø  Schedule work to employees and track daily output requirements

Ø  Maintain all day to day rostering for packaging staff, including leave coverage

Ø  Ensure all production lines are running smoothing

Ø  Fault finding and problem solving experience, in both mechanical and electrical systems

Ø  Troubleshoot problems and arrange for maintenance team to attend equipment repairs

Ø  Provide leadership, advice, coaching & support for staff

Ø  Facilitating effective communication between shift teams

Ø  Ensure employees adhere to company policies and legal regulations

Skills:

Ø  Minimum 5 Years experience as a Supervisor/Manager in a manufacturing environment

Ø  Electrical Trade qualifications

Ø  Experience in pharmaceutical, food, packaging or related industries

Ø  Pneumatics/hydraulic or mechanical fittings skills

Ø  Working knowledge and ability to interpret the Australian Code of GMP

Ø  High level of attention to detail, initiative and strong work ethic

Ø  Strong personal organisational skills with the ability to manage multiple tasks and priorities

Ø  Advanced problem solving and analytical skills

Ø  Strong ability in planning and organising

Ø  Superior communication and relationship building skills

Ø  Advanced analytical skills including Microsoft Excel/Word/PowerPoint

Good written and verbal communication skills together with knowledge of basic computer work, could make you the successful candidate for this role.  A strong awareness of Chinese culture and language would also be an advantage.

If you feel you have the above experience and skill set, submit your covering letter and resume via Seek.

Only applicants selected for interview will be contacted.

All other applicants are thanked for their interest

Maintenance Fitter

Ø  Leading Healthcare Manufacturer

Ø  Exciting Opportunity in Growing Organisation

Ø  Fast Paced, Dynamic Working Environment

Sphere Healthcare is a leading Australian-owned contract manufacturer of Complementary Healthcare Products, based in Sydney with easy access to major motorways.

We are currently recruiting for an experienced and motivated individual to work within our Engineering department.  Reporting to the Engineering Supervisor the role will be responsible to provide technical support to reduce equipment downtime by working closely with line operators and other trades people.

To be successful in this role you must demonstrate strong communication skills at all levels, strong attention to detail, root cause analysis/problem solving skills and the ability to work within a multi skilled team environment.

The Role:

Ø  Setting up and operation of processing equipment

Ø  Plan and carry out line change over’s to meet production needs

Ø  Ensure all lines are running smoothly

Ø  Able to repair mechanical equipment such as gear boxes, mechanical seals and conveyor systems

Ø  Fully conversant and compliant with all GMP factory maintenance

Ø  Able to operate workshop equipment and tools

Ø  Perform preventative maintenance and breakdown work

Ø  Must be physically fit and prepared to stand as required

Skills:

Ø  Maintenance/line setting experience in pharmaceutical or allied industry

Ø  Trade qualifications

Ø  Re-connect/Disconnect license is an advantage but not essential

Ø  Basic pneumatics, hydraulics skills

Ø  Adaptable individual with good work ethic

Ø  Able to work unsupervised

Ø  Achieve challenging deadlines

Ø  Successfully complete GMP Introduction & Selection quiz

Good written and verbal communication skills together with knowledge of basic computer work, could make you the successful candidate for this role.  A strong awareness of Chinese culture and language would also be an advantage.

If you feel you have the above experience and skill set, submit your covering letter and resume via Seek.

Only applicants selected for interview will be contacted.

All other applicants are thanked for their interest.

Facility & Environmental Cleaner

Sphere Healthcare is a leading Australian-owned contract manufacturer of Complementary Healthcare Products, based in Sydney with easy access to major motorways.

We are currently recruiting for an experienced industrial cleaner to work in our manufacturing facility. The Facility & Environmental Cleaner will need to have very high attention to detail and be responsible for the compliance of environmental legislation in accordance the requirement of GMP and SOP’s.

Individuals looking to apply must have experience working in a regulated environment, be reliable and punctual self starters. The positions will require flexibility as there is the possibility that overtime hours will from time to time be on offer.

The Role:

• To ensure the premises are maintained according to cleaning SOP’s
• Maintaining production floors using floor scrubber
• Filling hand wash dispensers with approved chemicals
• General cleaning of amenities and wash rooms
• Collection of rubbish and emptying of bins
• Ensure that all cleaning items are stored in their proper locations
• Use equipment in accordance with the issued instructions
• Awareness of and adherence to GMP, TGA and HACCP standards
• Observe WH&S standards including manual handling of containers up to 25 Kg

Skills:

• Hold a minimum of 1 years’ industrial cleaning experience in a manufacturing or food environment
• Experience working with chemical use and complying with strict requirements of chemical rates
• Forklift license preferred but not essential
• Ability to prioritise tasks and manage time effectively
• Must be physically fit (manual handling required) and have a hard working attitude
• Must be available for work Monday to Friday (we need consistency)
• Successfully complete GMP Introduction & Selection quiz

Good written and verbal communication skills together with knowledge of basic computer work, could make you the successful candidate for this role.  A strong awareness of Chinese culture and language would also be an advantage.

If you feel you have the above experience and skill set, submit your covering letter and resume via Seek.

Only applicants selected for interview will be contacted.

All other applicants are thanked for their interest.

Regulatory Affairs Officer

• Leading Contract Manufacturer
• Exciting Permanent Opportunity
• Fast Paced, Dynamic Working Environment

Sphere Healthcare is a leading Australian-owned contract manufacturer of Complementary Healthcare Products, based in Sydney with easy access to major motorways.

We are currently seeking a Degree qualified Regulatory Affairs Officer to join our Technical Department on a full time basis. The candidate will be responsible for the preparation of specifications, manufacturing and packaging documentation to meet all the required GMP and TGA regulatory standards.  Individuals looking to apply must be reliable, punctual self starters motivated by team work.

Role Responsibilities:

• Develop Specification and Regulatory documentation
• Develop internal and external customer Specifications
• Prepare master manufacturing and packaging Documents
• Assist with the development of regulatory policies and procedures
• Conduct material assessments to comply with quality standards
• Participate in the planning and process flow of products through manufacturing
• Provide technical/regulatory guidance and support to internal and external stakeholders

Skills & Experience:

• A Bachelor of Science or equivalent in Chemistry
• At least four years experience in the pharmaceutical or an allied industry
• Working knowledge and ability to interpret Australian code of GMP and TGA regulations
• Pharmaceutical formulation development
• Knowledge of national & international pharmaceutical regulatory requirements
• High level of attention to detail, initiative and strong work ethic
• Self starters able to work on their own or as part of a team to achieve challenging deadlines

Good written and verbal communication skills together with knowledge of basic computer word processing, spreadsheets, MRP and SAP software systems could make you the successful candidate for this role.  A strong awareness of Chinese culture and language would also be an advantage.

If you feel you have the above experience and skill set, submit your covering letter and resume via Seek.

Only applicants selected for interview will be contacted.

All other applicants are thanked for their interest.

NPD Technologist

• Leading Contract Manufacturer
• Exciting Permanent Opportunity
• Fast Paced, Dynamic Working Environment

Sphere Healthcare is a leading Australian-owned contract manufacturer of Complementary Healthcare Products, based in Sydney with easy access to major motorways.

As the NPD Technologist, you will be the key conduit between Sales, R&D, Technical and Operations to deliver all new product projects across multiple categories.  The successful candidate will play a key role in turning innovative concepts in to tangible new products.  You will work closely with multiple business units to achieve set deadlines and will own the overall NPD process end to end.

To be successful in this role you should have at least 3 years New Product Development experience and ideally you will come from a Pharmaceutical or FMCG background.  Project management experience will be essential to ensure that all product initiatives are delivered to the end market on time and within budget.

Role Responsibilities:

• Identifying gaps in the market and develop concepts to maximize business opportunities
• Provide enhancements to existing products
• Liaise with local suppliers and internal R&D team
• Product launch and project implementation
• Conducting pilot plant and factory test runs
• Quality control and ensuring the implementation of quality control standards are met
• Performing  cost/benefit analysis on new product concepts
• Assisting in the management of department KPI’s
• Developing and maintaining working relationships with key internal customers

Skills & Experience:

• A tertiary qualification in Naturopathy, Food Science or related subjects
• Experience in product development of short shelf life consumer products
• Exposure to working with flavor enhancers and herbal formulations
• Sound knowledge of Organic Superfoods would be viewed favourably
• Comprehensive understanding of category, marketing and brand planning
• Proven ability to take complicated information and communicate effectively
• Pro-active, high initiative and highly organized
• Ability to manage multiple tasks, priorities and improve efficiencies
• Time management skills to achieve deadlines, work under conflicting time pressures
• Commitment to delivering excellent customer service to suppliers and customers

Good written and verbal communication skills together with knowledge of basic computer work processing, spreadsheets, MRP and SAP software systems could make you the successful candidate for this role.  A strong awareness of Chinese culture and language would also be an advantage.

If you feel you have the above experience and skill set, submit your covering letter and resume via Seek.

Only applicants selected for interview will be contacted.

All other applicants are thanked for their interest.

R&D Chemist

• Leading Healthcare Manufacturer
• Exciting Permanent Opportunity
• Fast Paced, Dynamic Working Environment

Sphere Healthcare is a leading Australian-owned contract manufacturer of Complementary Healthcare Products, based in Sydney with easy access to major motorways.

We are currently seeking an energetic, motivated and results driven R&D Chemist. With a “hands on” approach we will challenge your skills in this critical role.  Our current product portfolio covers soft gel & hard gel capsules, tablets, liquids, creams and powder products.  Formulation experience with all these products would be an advantage to deliver technical advice to our manufacturing environment. 

The successful applicant will work within a team that provides a practical, outcome-orientated approach to process and product development as well as providing assistance toward New Product Development. With a strong commitment to standards, quality and safety values, the team perform R&D on new materials, processes and method development to drive operational improvements across the business.

Role Responsibilities :

• Develop and present new production formulations
• Scale-up of approved formulations
• Conduct new product development trials
• Identify and implement techniques to drive improvements
• Provide technical and hands on support to QA and Production
• Ability to solve problems with materials and methods during manufacture
• Engage in day-to-day troubleshooting
• Able to improve current and write new SOP’s
• Ensure adherence to quality requirements, GMP, regulatory compliance and general housekeeping
• Liaising with customers and clients on technical issues as required

Skills & Experience:

• A Bachelor of Science or equivalent in Chemistry  
• At least five year’s experience in pharmaceutical or an allied industry
• Formulating experience ideally covering tablets, hard gel & soft gel capsules, liquids/creams and powder products
• Working knowledge and ability to interpret the Australian cGMP and TGA regulations
• High level of attention to detail, initiative and strong work ethic
• Advanced problem solving and analytical skills
• Strong ability in planning and organising
• Self starters able to work on their own or as part of a team to achieve challenging deadlines

Good written and verbal communication skills together with knowledge of basic computer word processing, spreadsheets, MRP and SAP software systems could make you the successful candidate for this role.  A strong awareness of Chinese culture and language would also be an advantage.

If you feel you have the above experience and skill set, submit your covering letter and resume via Seek.

Only applicants selected for interview will be contacted.

All other applicants are thanked for their interest.

QC Laboratory Analyst

• Leading Contract Manufacturer
• Exciting Permanent Opportunity
• Fast Paced, Dynamic Working Environment

Sphere Healthcare is a leading contract manufacturer of Complementary Healthcare Products, based in Sydney with easy access to major motorways.

We are currently seeking a Laboratory Analyst to join the Quality Control team on a permanent basis.  With a “hands on” approach the successful candidate will be primarily responsible for the routine analysis of raw material and finished product within the QC laboratory. 

We will challenge your skills in this critical role to maintain the integrity of our quality products.  Individuals looking to apply must be reliable, punctual self starters motivated by team work.

The Role:

• Routine analysis of raw material and finished product using compendia and in-house methods
• Analysis of stability samples and validation samples as required
• Calibration of laboratory instrumentation
• Laboratory administrative and housekeeping duties as required
• Strict adherence to the highest standards of GLP and GMP at all times
• Observe WH&S standards

Skills:

• Tertiary qualification in chemistry, pharmacy, pharmaceutical science or other related discipline
• Experience with UPLC, HPLC (Empower), GC, AA/ICP-OES, HPTLC would be an advantage
• Demonstrated skills in laboratory analytical techniques including wet chemistry and/or instrumental techniques.
• Knowledge of and ability to maintain excellent GLP & GMP requirements and housekeeping
• High level of computer literacy
• Attention to detail, the ability to take the initiative and demonstrate a high work ethic
• Excellent written and verbal English interpersonal communication skills, effective Team Player within a challenging environment
• Flexibility; ability to work in an environment where priorities and deadlines change on a frequent basis
• Self starters able to work autonomously or as part of a team to achieve challenging deadlines

Good written and verbal communication skills together with knowledge of basic computer work, processing spreadsheets and experience with Quality Control Procedures and accreditation could make you the successful candidate for this role.  A strong awareness of Chinese culture and language would also be an advantage.

If you feel you have the above experience and skill set, submit your covering letter and resume via Seek.

Only applicants selected for interview will be contacted.

All other applicants are thanked for their interest.

WH&S Advisor (Part - Time)

• Leading Contract Manufacturer
• Exciting Part Time Opportunity
• Fast Paced, Dynamic Working Environment

Sphere Healthcare is a leading contract manufacturer of Complementary Healthcare Products, based in Sydney with easy access to major motorways.

As the WHS Advisor, you will use your skills and experience to maintain the Safety Management System (SMS) in line with current legislation.  The successful applicant will be required to maintain and continue to improve our workplace safety culture, identify and effectively manage workplace hazards and risks while ensuring the safety and well-being of all employees, contractors and visitors.

This is a new position that will reward a mature individual who enjoys maintaining exceptional professional standards and assisting key stakeholders comply to recognised standards of safety.

Role Responsibilities:

• Develop and implement WHS guidelines and policies
• Develop and coordinate relevant WH&S training 
• Accident/ Incident Investigation & Reporting
• Review and continued development of risk assessments
• Provide regular WHS Statistical reports and data
• Manage Workers Compensation claims and Return to Work Plans
• Ensure records are maintained and compliant in line with WHS legislation
• Continual development/monitoring/improvements of WHS systems

Skills & Experience:

• Certificate IV in WHS and/or extensive experience as a WHS Advisor
• RTW Certification (preferred)
• Training experience (Certificate IV Training & Assessment preferred)
• Exposure to Manufacturing/Warehousing industries
• Strong understanding of relevant legislation
• Experience in delivering training sessions and toolbox talks
• Formal training in Incident Investigation 
• Effective communication and interpersonal skills working with a variety of different backgrounds
• Attention to detail, initiative and good work ethics

Good written and verbal communication skills together with knowledge of basic computer work, processing spreadsheets and Content Management System (CMS) software could make you the successful candidate for this role.  A strong awareness of Chinese culture and language would also be an advantage.

If you feel you have the above experience and skill set, submit your covering letter and resume via Seek.

Only applicants selected for interview will be contacted.

All other applicants are thanked for their interest.

Customer Accounts Representative

Sphere Healthcare is a leading Australian-owned contract manufacturer of Complementary Healthcare Products, based in Sydney with easy access to major motorways.

We have the perfect opportunity for a polished and mature individual to join our dynamic and pivotal sales team. Working with our customers means you'll be working alongside some of our industry's more recognised entities, giving you the opportunity to contribute to Australia's ever growing complementary healthcare range.

Reporting to one of our Key Account Executives you will be in a position where you can display your excellent communication and interpersonal skills in order to build relationships with key internal and external stakeholders.

You will also be responsible for:

• Creating and sending invoices to customers
• Processing and cross checking orders and delivery dockets
• Answering customer phone calls and responding to email enquiries
• Analyzing and maintaining weekly and monthly reporting requirements
• Ensuring customer reports are accurately maintained
• Data entry, using Excel and SAP systems
• Administration duties as required
• Assisting in the management of department KPI's

Skill Requirements Include:

• Hold a high school or TAFE Certificate
• Have excellent communication and PC skills
• Ideally be proficient in SAP functions and experienced in Excel
• Proven ability to take complicated information and communicate effectively
• Ability to process large volumes of data
• Pro-active, high initiative and highly organized
• High level of attention to detail, initiative and strong work ethic
• Ability to work autonomously and within a team
• Superior attention to detail and accuracy
• Ability to manage multiple tasks, priorities and improve efficiencies
• Time management skills to achieve deadlines, work under conflicting time pressures

Good written and verbal communication skills together with knowledge of basic computer word processing, spreadsheets, MRP and SAP software systems could make you the successful candidate for this role.  A strong awareness of Chinese culture and language would also be an advantage.

If you feel you have the above experience and skill set, submit your covering letter and resume via Seek.

Only applicants selected for interview will be contacted.

All other applicants are thanked for their interest.

Manufacturing Operator

We are currently recruiting for an experienced and motivated individual to work within our Compression department.  The role will involve varied work in a busy manufacturing / production environment from set up and operation of machinery, all aspects of solid dose compression right through to completing batch documentation per instructions and quality standards.

The successful would ideally have Compression experience and be able to hit the ground running.  The position would suit individuals with experience working in a regulated environment who are energetic, motivated and willing to work from 6:00am to 2:30pm Monday to Friday.

The Role:

• Familiar with all aspects of compressing tablets/capsules operating a tablet press/compression machines such as FETTE, JMCO or Zanasi
• Experience in product changeover and machine setup / cleaning
• Conduct preventative maintenance
• Ability to follow written instructions and record process information
• Produce quality products ensuring minimal production time and wastage
• Completion & recording of in-process quality checks to GMP standards
• Effectively clean equipment & maintain quality, GMP and housekeeping standards
• Work efficiently through personal organization and planning to meet production targets
• Observe WH&S standards including manual handling of containers up to 25 Kg
• Must be physically fit and prepared to stand as required 

Skills:

• Previous experience in pharmaceutical or allied industry
• At least 2 years experience operating tablet press/compression machines
• Ability to work with powder products
• High level of attention to detail, initiative and strong work ethic
• Awareness of the Australian Code of GMP & TGA regulations
• English skills necessary to complete written documents
• Takes full responsibility for your work, maintaining output and quality
• Ability to prioritise tasks and manage time effectively
• Must be physically fit (manual handling required) and have a hard working attitude
• Must be able to work Full Time
• Successfully complete GMP Introduction & Selection quiz

We are looking to fill this role as soon as possible.  If you have relevant experience this is a great opportunity to work in a supportive and friendly environment for a well-extablished compnay, please forward a resume and covering letter to:

Mail: Human Resources
Sphere Healthcare Pty Ltd
PO Box 566, Moorebank NSW 1875
Fax:(02) 9822 7100
Email: hr@spherehealthcare.com.au

Please note only applicants that meet our criteria will be shortlisted for an interview