Our client is a globally leading pharmaceutical company whose innovative medicines continue to benefit millions of people all over the world. They are seeking an experienced QA Representative Biotech to join their Large Molecule Operations Team. The role will be based in their manufacturing site in Cork.
- Review and approval of other key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documents.
- Review and approval of change controls, observations/ deviations, failure investigations, suspect analytical results, product quality complaints, stability studies and reports associated with the manufactured batches.
- Review and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes, stability data, sampling protocols and Annual Product Reviews.
- Re-identification, re-evaluation & disposition of raw materials, intermediates and packaging components used in the manufacture of relevant pharmaceutical products where necessary.
- Batch disposition support, including approval of batch records, for DS and Intermediate batches.
- Evaluation and contribution of regulatory information to regulatory documents.
- Monitoring of GMP compliance, GMP programs and systems by ensuring a regular presence in the area of responsibility.
- Participation in the Site Self-Inspection program and audit of production, systems and service areas for compliance with Product Quality Systems, policies, guidelines and procedures.
- Reports and escalates critical quality issues to the appropriate level of quality management for final resolution.
- BSc, MSc, or PhD in Chemistry, Engineering or related discipline.
- 2 years' experience in a similar role.
To learn more about this role apply online or contact Paul Wheatley on +353 873449559 for a confidential discussion.