QA Specialist - Contract
|Title||:||QA Specialist - Contract|
|Sector||:||Scientific & Laboratory|
|Tel||:||021 201 9097|
Role of this position
- Provide Quality leadership, direction and governance for the specific area of responsibility
- Monitoring of GMP compliance, GMP programs and systems by ensuring a regular presence in the area of responsibility
- Approval/review of batch records.
- For biopharma supporting role, provide support to the QP for batch certification of Biotech drug substance materials OR for pharma supporting roles, perform batch disposition activities (API material)
- Review and approval of Trackwise change controls, 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
- Review and approval of other key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documents
- Approval of raw materials, intermediates and packaging components used in the manufacture of pharmaceutical products, using SAP
- Evaluation, audit and approval of 3rd party vendors of raw materials, intermediates and packaging components.
- BSc (Hons) Micro, Engineering, Biochemistry, Chemistry, Analytical or a related discipline
- Ideally a minimum of 3 years QA experience.
- Strong analytical and technical skills.
- Problem solving skills – resolution and prevention measures.
- Ability to network internally and externally to benchmark processes/systems
Please call JP O'Connor today for further information on 021 201 9097 or email: firstname.lastname@example.org
IN SEARCH OF EXCELLENCE
Specialists in the recruitment of Senior Management, Operations, Technical/Engineering, Senior Supply Chain & Quality personnel, Supporting Business Demands & Growth since 1999