LSC have a great contract opportunity a QA Specialist to join a leading biotech company based in Cork!
If you have a minimum of 5 years experience in a quality or compliance role within the biological and/or pharmaceutical industry and a ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Supports GMP activities from operational through to Laboratory support programs.
o Partners with other Departments to ensure that compliance programs are completed in an efficient manner and are effectively maintained.
o 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.
o Quality oversight of project activities including but not limited to, C&Q activities and process validation through to commercial manufacture.
o Participates as a key quality member in inspections and audits by external parties/agencies.
o Key participant within the QA team in the execution of their duties.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Bachelors Degree in a scientific/technical discipline required
o Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
o Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
o Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
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!
To apply, submit your CV via this advert or contact Ciaran Murphy at LSC on 021-4777329 if you have anymore questions about this QA Specialist opportunity!