Quality Specialist (hybrid)
RK24306
Contract 11 months
Tipperary





We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.




The Quality Specialist 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.




Key Responsibilities:

• 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.
• 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.
• Completes audits of data, information, procedures, facilities, equipment and systems (inc computer systems) to ensure compliance to SOPs, GMPs and applicable regulations. Keep abreast of cGMP requirements as described in applicable worldwide regulations.
• Additional activities may be assigned by the manager/supervisor

• Minimum qualification B.Sc. or M.Sc./ M.Eng Engineering or Science discipline
• 3 years of relevant post-degree experience in a GMP environment
• Experience withcomplaints and deviation investigations, change controls and CAPA’s.