Quality Assurance Manager

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:

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

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

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

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

• Investigate and troubleshoot any production incidents

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

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

• Participate in Investigations including Root Cause Analysis & Risk Assessments

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

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

• Manage Product Quality Reviews and liaise with sponsors

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

• Perform Compliance Trend Analysis as defined in relevant organizational procedures

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

Skill Requirements Include:

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

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

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

• 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

• Experience working with SAP will be an advantage

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

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

• 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.  

If you feel you have the above experience and skill set, submit your covering letter and resume to: hr@spherehealthcare.com.au

Only applicant selected for interview will be contacted.

All other applicants are thanked for their interest.

Documentation Support Officer

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 Document Support Officer to join our Technical Department on a full time basis. Reporting to the Regulatory Affairs Supervisor, the candidate will be responsible for the preparation of export document requests and complete customer documents in a timely professional manner. The individual must meet all required GMP and TGA regulatory standards whilst being reliable, punctual self starters motivated by team work.

Role Responsibilities:

Ø  Complete customer documents request such as allergen sheets

Ø  Prepare and gather export documents

Ø  Create and arrange letters/declarations

Ø  Data entry in operational software such as SAP

Ø  Assist in organizing packaging documents for internal and external personnel

Ø  Assist with the development of regulatory policies and procedures

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

Applications are welcome from individuals with the following:

Ø  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. 

Sphere Healthcare encourages a positive employee culture based on caring for our employees. 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

Validation Engineer

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

We are seeking a Validation Engineer who will be responsible for the creation, execution, documentation, reporting and administration of validation protocols for manufacturing processes, equipment, facility, cleaning and computer systems. Validation activities require structured quality risk management, in accordance with current regulatory requirements and industry best practices.

Role Responsibilities:

• Ensure compliance to all validation lifecycle requirements

• Creation and maintenance of Validation Project Plans, including Site Validation Master Plan

• Validation Protocol Preparation including URS, DQ, IQ, OQ & PQ.

• Execution of Validation activities and report preparation

• Integration of Quality Risk Management into all validation activities

• Validation review and scheduling of revalidation activities

• Co-ordinate validation and commissioning of new equipment

Key Requirements:

• Bachelor's degree in Science, Engineering or related discipline

• 5 years experience in a similar role within the Pharmaceutical or Complementary Medicines industry

• Knowledge of, and ability to interpret validation principles and regulatory

requirements

• Experience in process, cleaning, equipment, facility and computer system

qualification

• Knowledge of continuous improvement and risk based methodologies

• Excellent Communication and Organisational skills

• Demonstrated effective Project Management and superior Computer Literacy

• Statistical software skill competency, desirable

• OTC facility experience; desirable

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.

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 thanks for their interest.

QC Laboratory Analyst

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

We are currently seeking Laboratory Analysts to join the Quality Control team on a permanent basis.  With a “hands on” approach the successful candidates 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 candidates 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 – Medicine Mix (Afternoon Shift)

We are currently recruiting for an experienced and motivated individual to work within our Softgel department. The role will involve varied work in a busy manufacturing / production environment from dispensing raw materials, preparation of slurry and manufacture of medicine mix to completing batch documentation as per instructions and quality standards.

The successful candidate must possess sound knowledge, skill and 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 Full Time.

 The Role:

•  Ability to read and follow  the instructions in the batch document

• Dispense raw materials using 3WS

• Dispense oil and solid materials to prepare slurry

• Manufacture Medicine Mix in accordance with batch documentation and SOP’s

• Perform in-process quality checks and record results

• Effectively clean & perform general equipment maintenance

• Work efficiently through personal organization and planning to meet production targets

• Maintain quality, GMP and housekeeping standards

• Observe WH&S standards including manual handling of containers up to 25 Kg and able to handle drums using Drum Lifter

• Must be physically fit and prepared to stand for long periods of time

 Skills:

•  Experience in pharmaceutical or allied industry is preferred

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

• Awareness of the Australian code of GMP & TGA regulations

• Excellent English skills to produce written documents

• Be a pro-active and flexible self starter

• Ability to multi task and achieve challenging deadlines

• Successfully complete GMP Introduction & Selection quiz

 Sphere Healthcare is an equal opportunity employer that values diversity.  We are looking to fill this role as soon as possible and encourage all suitable applicants to apply.

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

Only applicants selected for the interview will be contacted.

All other applicants are thanked for their interest.

Manufacturing Operator - Gel Cooking (Day and Afternoon Shift)

We are currently recruiting for an experienced and motivated individual to work within our Softgel department. The role will involve varied work in a busy manufacturing / production environment from dispensing raw materials, gelatin manufacture and colour preparation to completing batch documentation as per instructions and quality standards.

 The successful candidate must possess sound knowledge, skill and 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 Full Time.

The Role:

• Ability to read and follow instructions as per batch document

• Dispense raw materials

• Set up and operate mixing, milling and gelatin melter

• Manufacture geletin mass in accordance with batch documentation and SOP’s

• Prepare slurry and blend into gelatin mass

• Perform in-process checks and record results 

• Effectively clean & perform general equipment maintenance

• Work efficiently through personal organization and planning to meet production targets

• Maintain quality, GMP and housekeeping standards

• Observe WH&S standards including manual handling of gelatin bags up to 25 Kg

• Must be physically fit and prepared to stand for long periods of time

Skills:

•  Experience in pharmaceutical or allied industry is preferred

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

• Awareness of the Australian code of GMP & TGA regulations

• Excellent English skills to produce written documents

• Be a pro-active and flexible self starter

• Ability to multi task and achieve challenging deadlines

• Successfully complete GMP Introduction & Selection quiz

Sphere Healthcare is an equal opportunity employer that values diversity.  We are looking to fill this role as soon as possible and encourage all suitable applicants to apply.

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

Only applicants selected for the interview will be contacted.

All other applicants are thanked for their interest.

Electrician

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

We are currently recruiting for a trade qualified individual with an electrical licence to join our Engineering team.  Reporting to the Engineering Supervisor the role will be an excellent opportunity to utilise your expertise in the areas of preventative maintenance, breakdown maintenance and improving Plant and Equipment operating efficiencies, adding value in a multi-skilled production environment.

The successful candidate would ideally have an analytical and methodical approach to problem solving and good communication skills.  The position would suit individuals who are self-motivated, with the ability to work as part of an efficient team.  While this is Monday to Friday position you will on occasion be required to work weekends for maintenance and capital projects.

Previous experience gained from the pharmaceutical, food, packaging or related industries is desirable.  Sound knowledge and expertise in machine automation and PLC systems.

The Role:

• Read electrical and mechanical diagrams, drawings or specifications to determine job requirements

• Install electrical and electronic control systems and insulated cables

• Connect electronic equipment to power supplies

• Able to program and fault find PLC logic

• Ensure all production lines are running smoothly

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

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

• Fully conversant and compliant with all GMP factory maintenance

• Able to operate workshop equipment and tools

• Perform preventative maintenance and breakdown work

Skills:

• Experience in pharmaceutical, food, packaging or related industries

• Trade qualifications

• Basic pneumatics, hydraulics skills

• Adaptable individual with good work ethic

• Able to work unsupervised

• A strong commitment to and understanding of WHS requirements

• Achieve challenging deadlines

• Flexible attitude to hours and work duties

• Successfully complete GMP Introduction & Selection quiz

Sphere Healthcare is an equal opportunity employer that values diversity.  We are looking to fill this role as soon as possible and encourage all suitable applicants to apply.

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

Only applicants selected for an interview will be contacted.

All other applicants are thanks for the interest.

QA Officer

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 for full time work in a challenging role.  The successful candidate will be reporting to the QA Manager and will be responsible for the performance of routine batch document review and release of Intermediates, Bulk & Finished Products within the QA Team.

The candidate will have superior attention to detail and a demonstrated ability to critically review manufacturing & packaging documentation with respect to compliance to all 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:

• Review of batch documentation and release of batches of Intermediates, Bulk & Finished Products in compliance to all relevant     regulatory standards

• Create, review & / or authorise all relevant Process Deviations required during batch document review or batch release activities

• Facilitate Process Deviation Investigations including Root Cause Analysis & Risk Assessments

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

• Contribute to the Internal Audit schedule and stakeholder feedback

• Perform Compliance Trend Analysis as defined in relevant organisational procedures

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

Skill Requirements Include:

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

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

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

• Excellent written, oral and 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

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

• Able to observe WHS standards

Good written and verbal communication skills together with knowledge of current GMP/ GLP as well as basic computer word processing, spreadsheets, could make you the successful candidate for this role.  

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.