QA Specialist (Hybrid)

QA Specialist (Hybrid)
RK23089
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.





Duties:

• Complete auditing/ review of batch documentation 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.
• Manage product recalls and stock recoveries as appropriate.
• Identify compliance gaps and make recommendations for continuous improvement
• Create and maintain assigned SOPs.
• Perform and review complaints and deviation investigations, change controls and CAPA’s.
• Assist in the induction process for new starters and training of other staff.
• Generally follows standard procedures and consults with manager/supervisor to ensure resolution of exceptions
• Compile data for reports and presentations, provide data interpretation, draw conclusions.
• Carry out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.
• Keeps abreast of cGMP requirements as described in applicable worldwide regulations.
• Represents department on cross functional teams.
• Assist in the generation, review and approval of Technical & Quality Agreements.
• Additional activities as assigned by the manager/supervisor Skills Required

• Bachelor degree in a Quality, Science or Engineering discipline and potentially a higher degree and/or significant industrial experience
• 3 years of relevant post-degree experience in a GMP environment