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QA Operations Specialist
il y a 1 mois
**Exothera** is a contract development and manufacturing organization (**CDMO**) dedicated to virus and viral vector production.
As a Univercells company, **Exothera **provides best-in-class bioprocessing expertise that capitalizes on novel manufacturing technologies. The company delivers accelerated process development/optimization to rapidly reach GMP clinical and commercial production of virus and viral vectors. At **Exothera **and **Univercells**, our mission is to make health equally accessible to all.
Based in Jumet you will join a **QA Operations** team and you will contribute to the start-up and operation of our brand new Exothera pharmaceutical manufacturing site for viral vectors.
As **QA Operations Specialist **you will be part of the QA department and you will provide the link between the manufacturing operations and the quality system to safeguard the quality, safety, and efficacy of pharmaceutical products and the cGMP conditions of the manufacturing processes and area.
You will be the on-the-shopfloor QA partner for the manufacturing team ensuring cGMP compliance status of activities.
**RESPONSIBILITIES**
In relation to the Quality system you will:
- Provide on the floor QA support by advising and counseling on cGMP and related quality assurance issues to the value stream
- Establish, implement, maintain and continuously improve QA Operations documents and documentation
- Initiate, participate, document, review, and approve operational risk assessments
- Take initiative to resolve deviation and OOS situations, participate in related investigations and review and approve related reports
- Review and approve change requests, related actions plans, and documentation
- Participate and provide training of personnel in relation to quality and cGMP requirements, both in classroom and shopfloor environment
- Perform annual product review activities
- Participate in self-audits, customer audits, and health authority inspections
In relation to the Production System you will:
- Review and approve operational cGMP documentation for completeness and compliance to cGMPs in line with regulatory requirements and internal procedures
- Issue and oversee the appropriate use of batch records
- Examines and evaluates production documentation, including batch records, in-process results, and other relevant production documentation; advice the Qualified Person on potential quality issues and disposition decision
In relation to the Materials System you will:
- Review and approve incoming materials documentation
- Release of incoming materials upon review of documentation
**REQUIREMENTS / QUALIFICATIONS**
We are looking for new colleagues with these required skills to support our ambitious goals:
- MSc or equivalent in a scientific discipline, engineering, or related discipline with the required skills, knowledge, and abilities that are typically acquired through experience in a biopharmaceutical manufacturing environment with cell culture activities.2 - 5 years of hands-on GMP experience in pharmaceutical QA, QC, MS&T, or sterile manufacturing environment
- Experience with single-use processes and equipment
- Experience or are highly interested in digital QA approach
- Moreover, you possess excellent problem solving (and master quality investigation techniques) You get energized by Teamwork
- You are able to define pragmatic solutions within the pharmaceutical regulatory framework
- You are fluent in French and English (both oral and written)
