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Purpose of the Position / Role Summary
Responsible for effectively maintaining site QA / QMS documentation systems. Responsibility for site Documentation review and QC testing activity for materials and finished product.
Key Role Specific Requirements
- Maintenance of all Site QMS systems, including retains and documentation archive.
- Maintain documentation control processes and issuing for all QMS systems.
- Review of Bimeda and third-party product release documentation and maintain MRP inventory status.
- Maintenance of finished product retains and the retain room including annual inspections.
- Complete incoming inspection and verification checks for receipt of human pharmaceutical product.
- Complete QA review documentation for QP batch release.
- Assist in the preparation of QA department Standard Operating Procedures (SOPs) and be responsible for document control issuing for SOP’s.
- Assist in the generation and maintenance of packing, artwork and material specifications.
- Assist in the generation and maintenance of artwork specification files and artwork request updates.
- Responsible for incoming QC inspection of all packaging components and materials and complete inventory release.
- QA Batch review of production dispensing / packing records and manufacturing records.
- Review of third party QC product testing reports, generation of batch Certificate of Conformity (CoC) and inventory release.
- Primarily responsible for packaging line set up approval and packed stock pallet approval checks.
- Completion of inhouse QC testing reports and draft Certificate of Analysis (CoA) for food and cosmetics batch testing.
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
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Competencies Required for the Role
Analytical Thinking/Problem Solving - Is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this.
Fostering Collaboration/Teamwork - Is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.
Effective Communication - Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen and show respect for oneself and others in interactions with others. Express oneself clearly in verbal and business writing.
Judgement - Is the ability to make considered decisions or come to a sensible conclusion.
Process Improvement - Involves the business practice of identifying, analyzing, and improving existing processes to optimize performance.
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Other Requirements
Essential:
- Experience /or demonstrated understanding of working in a regulated environment, GMP/GDP or Food Manufacture
- Strong analytical/quantitative skills
- Good computer skills with high proficiency in Microsoft Office.
- Self-initiating / self-directed
- Problem solving ability using robust tools
- An individual who is thorough and has a keen eye for detail.
Desirable:
- 2+ years’ experience within GMP Manufacturing
- Understanding of quality systems and cGMPs.
- Previous experience in a lab environment
About Bimeda
Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals.
Bimeda’s global innovation program sees six state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.
Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.
Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.
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More Info at www.bimedacareers.com
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