LSC have a great contract opportunity for a QA Specialist to join a leading biotech company based in Cork.
If you have a Bachelor's Degree in a scientific/technical discipline and a minimum of 5 years' experience in a quality or compliance role within the biological and/or pharmaceutical industry and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Managing compliance activities and QA operational activities related to operational project as required by Good Manufacturing Practice (GMP)
- These activities include, C&Q and Validation activities, Data Integrity and CSV support, change control, non-conformance investigations, compliance auditing, and other related quality system elements.
- Supports GMP activities from operational through to Laboratory support programs.
- Partners with other Departments to ensure that compliance programs are completed in an efficient manner and are effectively maintained.
- Responsible for implementation of systems and procedures for the management of change control and deviation management, as it applies to plant installations, systems, and operations in accordance with GMP.
- Quality oversight of project activities including but not limited to, C&Q activities and process validation through to commercial manufacture.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
- Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
- Experience in C&Q, and Process validation
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 +35321 4777329 if you have any more questions about this opportunity!