Quality Assurance Manager
- Experience Level
- Full-time permanent position
- Office based in Gloucestershire
- Competitive package
- Global pharma company
- Ensuring compliance with Company QA and GDP requirements.
- Ensuring consistent implementation of the QMS across the Company, including proactive management of:
- Initial qualification and ongoing/periodic validation of suppliers
- Initial qualification and ongoing/periodic validation of customers
- Change control
- Deviation management and Corrective Action and Preventive Action (CAPA) management
- Customer and supplier complaints
- Capturing key performance indicators (KPIs)
- Training (GDP training as well as other non-pharmaceutical related training programmes)
- Establishing, maintaining and controlling relevant Standard Operating Procedures (SOPs)
- Quality Risk Management
- Product Recall
- Record management and document retention
- Stock management practices
- Pre-distribution internal batch checks
- Providing QMS support to the Medical Affairs, Finance and Commercial departments
- Maintaining ongoing ISO 9001:2015 and ISO 14001:2015 certification
- Coordinating the communication and investigation of manufacturing deviations and product quality complaints.
- Control and preparation of PQRs.
Full job description available on application
- A degree in Pharmacy, Chemistry, Biology or a Biomedical Science.
- A demonstrable commitment to continuous professional development through self-directed learning and completion of appropriate training courses.
- Significant experience in the pharmaceutical industry, with solid knowledge and experience in the quality and compliance of medicines. A knowledge of injectable medicines would be useful.
- Proven experience of implementing/managing quality systems in a GxP environment.
- Integrity and application of sound professional judgement
- High levels of organisation and attention to detail with the ability to prioritise, plan and organise work in line with customer and business needs.
- Effective communication of information (written and verbal) at levels appropriate to the needs of healthcare professionals, regulatory bodies, business partners, internal customers and the general public.
- Only candidates with existing right to work in the UK/EU will be considered
Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on 01227 844466 or email firstname.lastname@example.org
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Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.