Quality Compliance Officer

We have the perfect opportunity for an individual looking to be a part of the Quality team. The successful candidate will be reporting to the QA Associate and will be responsible for the performance quality checks and approvals in fulfillment with SOP’s. The candidate will have superior attention to detail and a demonstrated ability to critically review manufacturing & packaging SOP’s and GMP with respect to 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  Involvement with Quality compliance within the manufacturing environment as well as GMP

Ø  Reviewing and assessing of current and new SOP’s relevant to the production area

Ø  Creating and updating current SOP’s that are compliant with WHS and GMP requirements

Ø  Developing and producing a SOP training program to reassess employee’s standards and abilities

Ø  Performing Quality process checks and approvals

Ø  Increasing Compliance with GMP Standards

Ø  Liaising with the Quality Team with issues that arise in Production 

Ø  Contribute to the collation & presentation of all QA Personal & Operational Key Performance Indicators

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 understanding of TGA regulation and its application in a manufacturing environment

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

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

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

Ø  Flexibility; ability to work in a fast paced environment where priorities and deadlines change on a frequent basis autonomously

Ø  Able to observe WHS standards

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-established company, please forward a resume and covering letter to:

Mail: Human Resources

Sphere Healthcare Pty Limited

P O Box 566, Moorebank NSW 1875

Fax: +61 2 9822 7100

Email: hr@spherehealthcare.com.au

Please note that we will only contact applicants that meet our criteria for interview.

Handyman

We are currently recruiting for an experienced and mature Handyman to work within our manufacturing facility.  As the Handyman you will need to have high attention to detail and be responsible for the general labour of the interior and exterior buildings. Individuals looking to apply must have experience working in a regulated environment, be reliable and punctual self starters who are willing to work.

The Role:

Ø  Required to complete general painting for the premises

Ø  General cleaning of outdoor areas and basic gardening/planting

Ø  Required to maintain well kept walkways and environments including the outdoor environment

Ø  Ensure that all cleaning and tool items are stored in their proper locations

Ø  Use equipment in accordance with the issued instructions and SOP’s

Ø  Completing minor repairs to the facility including basic carpentry and patching

Ø  General fixtures and fittings for the interior and exterior building

Ø  Awareness of and adherence to GMP, TGA and HACCP standards

Ø  Observe WH&S standards including manual handling

Ø  All duties to be performed in compliance with Work Health and Safety practices

Skills:

Ø  Hold a minimum of 1 year industrial trade experience

Ø  Experience working with chemical use and complying with strict requirements of chemical rates

Ø  Forklift license preferred but not essential

Ø  Ability to prioritize tasks and manage time effectively

Ø  Able to work autonomously and within a team

Ø  Must be physically fit (manual handling required) and have a diligent attitude

Ø  Successfully complete GMP and Aptitude quiz as well as an induction

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-established company, 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.

Regulatory Affairs Officer

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:

Ø  Develop Specification and Regulatory documentation

Ø  Develop internal and external customer Specifications

Ø  Prepare master manufacturing and packaging Documents

Ø  Assist with the development of regulatory policies and procedures

Ø  Conduct material assessments to comply with quality standards

Ø  Participate in the planning and process flow of products through manufacturing

Ø  Provide technical/regulatory guidance and support to internal and external stakeholders

Applications are welcome from individuals with the following:

Ø  A Bachelor of Science or equivalent in Chemistry

Ø  At least four years experience in the pharmaceutical or an allied industry

Ø  Working knowledge and ability to interpret Australian code of GMP and TGA regulations

Ø  Pharmaceutical formulation development

Ø  Knowledge of national & international pharmaceutical regulatory requirements

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

Ø  Excellent English skills to produce written documents

Ø  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.

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-established company, please forward a resume and covering letter to:

Mail: Human Resources

Sphere Healthcare Pty Limited

P O Box 566, Moorebank NSW 1875

Fax: +61 2 9822 7100

Email: hr@spherehealthcare.com.au

Please note that we will only contact applicants that meet our criteria for interview.

Sales Director

With its growth and expansion plans the business requires the skills of an experienced Sales Director who will work closely with a diverse range of complementary healthcare customers to develop strategic plans.

The role requires the individual to possess an analytical ability and professional selling skills. In addition to leading the sales team to bring in new business, the sale director will acquire knowledge of the manufacturing environment in order to best present future business and sell production capacity within the facility. The ideal candidate will need to have the passion and desire to connect and engage with senior executives across a number of major healthcare, beauty and lifestyle brand providers. 

The Role:

• Design new business initiatives to optimize revenue
• Design strategies to achieve market penetration and sales growth
• Define and communicate performance expectations and goals to the sales team.
• Manage and mentor the Sphere Healthcare sales team so they exceed required targets and business goals
• Develop and execute sales strategies and initiatives to create opportunities that enhance revenue and related sales
• Develop and implement plans to achieve long- term strategic objectives that drive the company forward
• Responsible for achieving new business revenue targets
• Reporting on performance against budget and other related sales
• Identifying and maintaining strategic partner relationships
• Responsible for  customer forecasting  and planning
• Develop strategies for winning new business that align to Sphere’s manufacturing capabilities
•  Manage your teams activities and processes including account planning, call cycles, customer tendering and targeting
• Plan and implement customer reviews  

Skills:

•  Demonstrates operational experience of at least 5 years in a sales management role
• Experience in creating and executing business wide sales strategies
• Excellent English communication and strong awareness of Chinese culture and language 
• Possess a deep understanding and the complementary healthcare market or allied industries
• Be proficient in utilizing analytical report tools such as SAP
• Exceptional personal organizational skills with the ability to manage multiple tasks
• Ability to meet deadlines and work under conflicting time pressures
• Capability to ensure and lead the sales team are motivated through appropriate coaching, mentoring and development
• Work values that complement the culture of the organization

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-established company, 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 that we will only contact applicants that meet our criteria for interview

GMP Cleaner

We are currently recruiting for an experienced GMP environmental cleaner to work in our manufacturing facility.  As the GMP Cleaner you will report to the Production Supervisor and be expected to have a high attention to detail and be responsible for the compliance of environmental legislation, the cGMP and SOP’s.  Note this is not a general cleaning role. 

Individuals looking to apply must have experience working in a regulated environment, be reliable and punctual self starters.  The position will require the successful candidate ensure the correct method of cleaning is applied to eliminate the risk of possible contamination at all times.

The Role:

• Cleaning large areas in production according to SOP’s within a scheduled time frame
• Ensuring production rooms are compliant and pass QC checks
• General cleaning of wash bays at a GMP standard
• Clean and sanitise all production equipment and wash all items with approved cleaning solution
• Wash all walls, platforms, drum lifters, stainless steel benches, floors, trolleys, deionised and town water outlets
• Clean all dust extraction pipes and outlets, pneumatic outlets, buckets and containers with hot water to remove product residue and dust particles
• Ensure that all cleaning items are stored in their proper locations
• After the completion of a batch, remove all cleaning status labels from the equipment and room clearance sheet and file with the batch document
• Use equipment in accordance with the issued instructions
• Familiarity with and adherence to GMP, TGA and HACCP standards
• All duties to be performed in compliance with Work Health and Safety practices

Skills:

• Hold a minimum of 1 year GMP cleaning experience in a TGA licensed manufacturing
• environment
• Experience working with chemical use and complying with strict requirements
• of chemical rates
• 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 available for 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-established company, 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.

Maintenance Fitters

We are currently recruiting for experienced and motivated individuals 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:

• Setting up and operation of processing equipment
• Plan and carry out line change over’s to meet production needs
• Ensure all lines are running smoothly
• Able to repair mechanical equipment such as gear boxes, mechanical seals and conveyor systems
• Fully conversant and compliant with all GMP factory maintenance
• Able to operate workshop equipment and tools
• Perform preventative maintenance and breakdown work
• Must be physically fit and prepared to stand as required

 Skills:

• Maintenance/line setting experience in pharmaceutical or allied industry
• Trade qualifications
• Re-connect/Disconnect license is an advantage but not essential
• Basic pneumatics, hydraulics skills
• Adaptable individual with good work ethic
• Able to work unsupervised
• Achieve challenging deadlines
• Successfully complete GMP Introduction & Selection quiz

We are eager to fill this role as soon as possible.  If you have relevant experience and are looking for an exciting opportunity to join a team making a difference to the health and wellbeing of individuals, 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

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