The Quality Auditor is a member of a team within Global Development Quality (GDQ) and is involved in supporting the GMP Quality Assurance activities for the GDQ IMP Licence at the site.
• Completes audits of data, information, procedures, facilities, equipment and systems (inc computer systems) to ensure compliance to SOPs, GMPs and applicable regulations.
• Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
• Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review.
• Support product recalls and stock recoveries as appropriate.
• Identify compliance gaps and make recommendations for continuous improvement
• Creates and maintains assigned SOPs.
• Perform and review complaints and deviation investigations, change controls and CAPA’s.
• May assist in the induction process for new starters.
• Generally follows standard procedures and consults with manager/supervisor on exceptions.
• Compiles data for reports and presentations - May interpret data and draw conclusions.
• Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.
• Keep abreast of cGMP requirements as described in applicable worldwide regulations.
• Additional activities may be assigned by the manager/supervisor
Experience, Knowledge & Skills:
• A degree in an Engineering or Science discipline.
• Alternatively, significant industrial experience will be considered.
FORCE (formerly Pharmaforce) is an Irish company that specialises in delivering Outsourcing and Recruitment services to the pharmaceutical, medical and healthcare sectors.
We help business grow, achieve revenue goals and save on both recruitment and management costs. Our proven track record and expert team makes us the go-to choice for companies looking to optimise their operations and achieve success in the industry.
We specialize in recruiting at all levels, from early-career professionals to skilled managers and executive leaders. Our expertise span various industries.