LSC have a great contract opportunity for a QA Specialist to join a global Biopharmaceutical company in Carlow. This is a state-of-the-art vaccines and biologics manufacturing facility currently producing many products in various therapeutic areas including: oncology, autoimmunity, pneumonia, and infectious disease.
If you have 3 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Provide quality oversight and direction for the introduction of new products and materials, as well as manage external parties.
- Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings.
- Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
- Review documentation associated with new product and material introduction, such as Material Packs, QC Test Specifications, BOMs, and MES documentation.
- Support deviation and atypical closeout, as well as initiate and follow up on corrective and preventive actions.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.
- Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices.
- Strong report, standards, and policy writing skills.
- Experience with equipment and process validation.
- Familiarity with sterile filling processes and equipment.
- Experience or familiarity with Lean Six Sigma methodology.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Grainne Hodnett at LSC on 021 4777329 if you have any more questions about this role!
