LSC have a great contract opportunity for Quality Assurance Specialist to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Qualification/ Validation activities whilst ensuring that all activities meet and regulatory expectations.
- Support a safe working environment by complying with all pertinent environmental health/safety practice, rules, and regulations
- Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
- Quality review/approval of BOMs, MBRs and recipes.
- Write, review, and approve Standard Operating Procedures in accordance with Amgen Policies.
- Perform all activities in compliance with safety standards and SOPs
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- University degree. Science or engineering related discipline preferred.
- Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for NPI/ technology transfer / product lifecycle changes.
- Understanding of principles of Validation and New Product Introduction
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 +353 214771329 if you have any more questions about this opportunity!