- Experience Level
- Experienced (non-manager)
- Provide Quality Assurance guidance and coaching to other departments to ensure compliance
- Consistently performs the tasks that are assigned to their role within Quality Assurance.
- Comprehensive understanding of cGMP procedures, how they relate in the larger regulatory environment and an ability to place them in context.
- Displays a good knowledge of QC and manufacturing equipment, utilities, facility design, cleaning, maintenance, qualification, validation, material management, on-boarding, and supplier qualification.
- Generation and review of Quality Assurance procedures and other documentation.
- Identifies & takes action to resolve issues as they arise across site. Supports in the in the root cause analysis and driving effective CAPA across all areas of the business to prevent recurrence.
- Monitoring Quality KPI’s - Monitor activities and identify trends, sets in place action plans to resolve identified trends and reports results to Line Manager..
- Participate and support internal audits and external audits/inspections.
- Trains junior members of the QA team, and site personnel, to develop & apply what they learn to their jobs.
- Generation and monitoring of KPI’s.
- Maintenance of QMS.
- QC method and equipment validation, qualifications, deviations and calibration.
- Product Quality Reviews.
- Production batch record reviews.
- Prepare COA/GMP statements, BSE/TSE and other certifications and statement of results.
- Manufacturing cleaning and decontamination certificates.
- Review and approval of production equipment (changes, deviations, qualifications, and calibration).
- Life Sciences Degree
- Previous experience working in Pharmaceutical, biotech or medical devices environment
- Excellent communication skills – clear, and timely written & verbal communication.
- Comprehensive knowledge and technical competence in Quality Assurance