QA Specialist (Systems) required for a market leading, top Ten Biopharmaceutical company based in Cork. The Cork campus is a team focused organisation, who work to ensure their medicines are delivered on time and to the highest possible quality.
Excellent opportunity for a QA Specialist to work as part of the Systems team.
Essential Duties and Job Functions:
o Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
o Assists with the maintenance of programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs).
o Completes the review/ approval of site Quality System & IT documentation (primarily validation related documentation).
o Generates annual product review reports, ensuring continued schedule adherence.
o May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to site quality systems.
Knowledge, Experience and Skills:
o Demonstrates knowledge of FDA/EMA standards and quality systems.
o Applies knowledge of current Good Manufacturing Practices (cGMPs) on a daily basis.
o Previous experience in the review/ approval of validation documentation desired.
o BSc degree and some years of relevant experience
Contact Claire at LSC on 021 4777 329 for more details, or apply directly via this advert.