Description
Global Biotech Company based in cork is currently seeking a QA rep to join their QA team.Responsibilities
- 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.
- Provide support to the QP for batch certification of Biotech drug substance materials
- 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.
- Participation in internal and external audits
- Communication and education of personnel in GMP requirements and regulations.
Basic Qualifications
BSc Micro, Engineering, Biochemistry, Chemistry, Analytical or a related discipline with a minimum of 3 years QA experience.
- Previous experience in a biotech GMP production environment essential, preferably in a quality role or a relevant technical support role.
- Strong analytical and technical skills.
- Problem solving skills - resolution and prevention measures.
- An excellent teamwork approach.
- Guidance of others through processes.
- Very strong communication and people skills - interaction with production, engineering, suppliers, other sites.
- Flexibility to change.
- Ability to network internally and externally to benchmark processes/systems
If you are interested in this role please contact me Anna Mooney or apply below with an up to date CV.