QA Operations Specialist for Qc- Exothera
il y a 4 heures
**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 processdevelopment/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.
**Mission**:
The QA Operations Specialist for QC provides the link between the Quality Control operations and the quality system to safeguard the quality, safety and efficacy of pharmaceutical products and the cGXP conditions.
The QA Operations Specialist is the on-the-shopfloor QA partner for the QC team
**Responsibilities**:
- Provide on the floor QA support by advising and counseling on cGMP/cGLP 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 QC 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
- Participate in self-audits, customer audits and health authority inspections
- Review and approve operational documentation for completeness and compliance to cGMP/cGLP in line with regulatory requirements and internal procedures
- Issue and oversee appropriate use of QC records including methods and equipment’s qualification
- Advice the Qualified Person on potential quality issues and disposition decision
- Review and approve incoming materials documentation
- Release of incoming materials upon review of documentation
**REQUIREMENTS and QUALIFICATIONS**
- MSc or equivalent in scientific discipline
- 5 years of hands-on GMP experience in pharmaceutical QA, QC, MS&T or sterile manufacturing environment
- Experience with typical QC methods in biotech environment: Elisa, SDS Page, PCR, in-vitro potency,
- Experience with digital QA and paperless QC approach
- Problem solving (incl. use of investigation techniques)
- Teamwork
- Able to define pragmatic solutions within the pharmaceutical regulatory framework
- Fluent in French and English
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