Summary:
A Quality Specialist is required to join a leading pharmaceutical company in South Tipperary, providing support across on-site GMP Quality Assurance activities. This role operates on a hybrid basis.
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 and 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.
Qualifications & Experience:
* Degree in Engineering or Science (or equivalent industrial experience)
* 3+ years' relevant experience in a pharmaceutical or biopharmaceutical GMP environment.
* Proven experience reviewing and approving batch, production and analytical documentation in line with SOPs, GMP and regulatory requirements, including support of QP certification.
* Strong working knowledge of quality systems, including deviations, change controls, complaints, CAPAs, audits and inspections.