LSC have a great contract opportunity for and QA Manager to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Cell based potency bioassays, lab operations and compliance.
If you have 4+ years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE ROLE:
- Maintenance of External Supply Quality licenses as it relates to global GMP/GDP activities (MIA, ASR, WDA).
- Ensuring the review, and where appropriate, preparation and regular update of Quality Agreements with outsourced partners.
- Owner and approver of GMP/GDP QMS documents.
- Support the annual Quality Management Review meeting and co-ordination of any actions from this meeting for implementation.
- Preparation and periodic review of Bona Fides.
- QA approval of deviations/non-conformances ensuring deviations are fully investigated and that remedial measures are implemented to address the root cause of failures and relevant actions are taken to prevent their re-occurrence.
- QA approval of change control proposals (third party contractors and internal) and action plans.
ARE YOUR SKILLS A MATCH:
- Doctorate degree OR
- Master's degree & 2 years of directly related experience OR
- Bachelor's degree & 4 years of directly related experience OR
- Associate's degree & 10 years of directly related experience.
- 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry.
Apply today directly through this advert or contact Kathy Gillen on 021 47718212 for further information. All applicants must hold a valid work permit and visa for at a least 12 months. LSC cannot provide work permit sponsorship.
