LSC have a great contract opportunity for a QC Microbiology Validation Specialist to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have 5 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:
- Support the planning, execution and completion of microbiological method validation, verification and qualification activities.
- Provide specialist support for New Product Introduction (NPI) and the development of QC Microbiology validation strategies.
- Author, review and execute validation protocols, test plans, data packages, summary reports and associated technical documentation.
- Perform routine and validation sample testing for bioburden and bacterial endotoxin in accordance with approved methods and procedures.
- Coordinate validation testing activities, sample requirements and documentation with QC Microbiology, Manufacturing, QA, Technical Transfer, Technical Services and project stakeholders.
- Investigate out-of-specification, out-of-limit and atypical results using Structured Problem Solving and Root Cause Analysis tools, and support effective corrective and preventative actions.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum of 5 years of experience in a cGMP Quality Control, microbiology or validation environment.
- Demonstrated experience in bioburden and bacterial endotoxin testing, including validation or verification activities.
- Experience supporting New Product Introduction, method transfer, method validation or qualification within the pharmaceutical or biopharmaceutical industry.
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 Amy Smyth on 021 4777329 if you have anymore questions about this role!
