QA SPECIALISTS x 2 required by CareerWise Recruitment for our Biologics client in Cork, initial 12 month contract on offer.
The QA SPECIALISTS will manage compliance activities and QA operational activities including C&Q and Validation activities, Data Integrity and CSV support, change control, non-conformance investigations, compliance auditing, and other related quality system elements.
Role of this position
- 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.
- Participates as a key quality member in inspections and audits by external parties/agencies.
- Key participant within the QA team in the execution of their duties.
- Executes the activities of the group within quality to create a synergistic approach to goals and tasks.
- Domestic and international travel may be required.
- Bachelors Degree in a scientific/technical discipline required
- A minimum of 3 years experience in a quality or compliance role within the biological and/or pharmaceutical industry.
- 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
- Experience in direct interactions with regulatory agencies during site inspections.
Please call Conor Twomey today for further information on 021 4297422 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)