LSC have a great contract opportunity for a Quality Services Senior Specialist to join a 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:
- Engage with internal and external stakeholders to plan and manage all testing of Pharma products at contract testing laboratories and CMOs
- Serve as analytical contact for CMOs and CTLs (associated with ExM), addressing analytical issues and requests while coordinating with relevant stakeholders.
- Review and approve laboratory investigations, deviations, and out-of-specification (OOS) events at CMOs and CTLs in partnership with method subject matter experts.
- Provide technical support to the Qualified Person (QP)/ Responsible Person (RP) and Quality Operations in relation to same
- Act as Lead Investigator for major analytical deviations, managing records as required.
- Review and approve analytical change controls from CMOs and CTLs, and assess the impact of change controls related to CMO/CTL analytical testing.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum B.A. or B.Sc. in life sciences plus 4 years in a QC GMP environment.
- In depth knowledge of Quality Management Systems relating to laboratory operations.
- Ability to ensure objective critique of analytical investigation reports from CMOs or CTLs.
- Previous experience using electronic document and deviation management systems.
- Working knowledge of analytical technical transfers.
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!
