- A vacancy has arisen for a Quality Specialist at our client’s busy pharmaceutical site in Co. Tipperary.
- The successful candidate will operate as part of the client’s Global Development Quality (GDQ) team which is involved in supporting the global GMP Quality Assurance activities for the IMP Licence at the site. This site licence is used to release all Clinical lots to Clinics in the EU and the Rest of World.
Core Duties and Responsibilities:
- 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
Education & Qualifications Required:
- Degree in a Quality, Science or Engineering discipline and potentially a higher degree and/or significant industrial experience.
- Must possess more than 3 years industrial experience.
- Excellent written and oral communication skills
- Capability to communicate the requirements to suppliers
- Use good documentation practices and be capable of implementing these at a local level.
- Works with moderate work direction and is skilled and knowledgeable to the position.
- Good working knowledge of cGMPs
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.