QA Specialist- Cork. 12-month contract. Days only. Location: Cork. Our client, a pharmaceutical company in Cork, is currently looking for an experienced QA Specialist to join their team. This role is to provide quality assurance support to Quality Manager including supporting the implementation and maintenance of the QMS with specific focus on distribution related activities. As Responsible Person, in line with EU and local regulations, maintain a high level of QMS and local regulatory knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential adversity with regards to GDP. 12- month contract- Excellent hourly rate - call Aoife on 086 044 3981. Responsibilities of QA Specialist Job: * Ensure compliance with the general conditions detailed, in line with European and local regulations while adhering to Good Distribution Practice (GDP. * Implement and maintain all aspects of the quality systems. * To ensure initial and continuous training programs are relevant and up to date. * Coordinate and perform recall operations for medicinal products. * Manage customer complaints, ensuring they are dealt with effectively. * To notify HPRA of any change of RP by way of variation to the Licence. * To manage self-inspections and perform at regular intervals. Requirements of QA Specialist Job: * Bachelor's Degree in a scientific/technical discipline required. * A minimum of 3 years' experience in a quality or compliance role within the pharmaceutical industry. * Formal certified GDP Training on Good Distribution Practice of Medicinal Products for Human Use. * Working knowledgeable 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. Strong Knowledge of regulatory requirements pertaining to GDP. Previous experience working as a Responsible Person advantageous. This job originally appeared on RecruitIreland.com.
63 days ago