LSC work exclusively in the Life Science sector; founded and run by contractors we understand contracting first hand and have created a unique solution to make the process as easy as possible - so you can focus on getting your work done!
At LSC we partner with you for the long term, not just your contract duration. We are committed to building relationships and will work with you to ensure you are placed on projects that challenge and reward you throughout your career.
LSC have a requirement for QA Validation Specialists to join a leading biopharma company based in Cork. As QA Specialist you will be managing compliance activities and QA operational activities related to operational project as required by 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.
As QA Validation your responsibilities will be:
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.
As QA Validation you will have:
o 3rd level degree in a science related discipline preferred.
o A minimum of 5 years' experience in a quality or compliance role within the biological and/or pharmaceutical industry.
o 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.
o Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
o Experience in C&Q, and Process validation
o Experience in direct interactions with regulatory agencies during site inspections.
For full details on these role please contact Kathy on 021 4777329 or apply directly through this advert