LSC have a great contract opportunity for a Quality Assurance Senior Associate to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
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 opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Ensure adherence to safety standards and SOPs in all activities.
- Review and approve production batch records and associated documentation for Qualified Person disposition activities.
- Provide real-time quality oversight and support for production unit operations, extending to formulation, vial and syringe Fill Finish activities, including media fills and assessment of aseptic interventions.
- Conduct inspections of vials and syringes as part of AQLs, annual reserve inspections, and support complaint investigations.
- Offer Quality Assurance support for on-the-floor investigations and deviations.
- Review and approve deviations for closure, ensuring compliance with appropriate documentation.
- Participate in customer complaint investigations.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor's degree in Science, Engineering, Pharmacy, Biotechnology, or a related discipline.
- Minimum 4 years' experience in the pharmaceutical or biotechnology industry.
- Demonstrated problem-solving abilities, particularly in supporting non-conformance/deviation investigations.
- Experience in inspecting vials and syringes and engaging in aseptic operations.
- Familiarity with applicable Regulatory requirements and proficiency in evaluating compliance issues.
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 Jenny Murphy on 021 4777329 if you have anymore questions about this role!
