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Quality Assurance Specialist - GMP
- cambridge, cambridgeshire, CB2, United Kingdom
- Permanent·Hybrid
- Full time
- £57,000 - £57,000 Per Annum
Job Description
About the Role
Our client is seeking a diligent and experienced Quality Assurance Specialist to join their team in Cambridge . This role is essential for ensuring that all pharmaceutical manufacturing and development processes adhere to stringent Good Manufacturing Practice (GMP) guidelines. You will play a key role in maintaining quality systems, conducting audits, and ensuring regulatory compliance. This hybrid position offers the chance to contribute significantly to product quality and patient safety while enjoying a flexible working arrangement within a leading scientific hub.
Key Responsibilities
- Implement and maintain the Quality Management System (QMS) in accordance with GMP regulations.
- Conduct internal audits of manufacturing processes, documentation, and facilities to ensure compliance.
- Review and approve quality-related documentation, including batch records, SOPs, and validation protocols.
- Investigate deviations, non-conformances, and CAPAs (Corrective and Preventive Actions).
- Participate in regulatory inspections and audits by external agencies.
- Provide training to personnel on GMP requirements and quality system procedures.
Requirements
- Bachelor's degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology) or a related field.
- Minimum of 3 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry, with a strong focus on GMP .
- In-depth knowledge of GMP regulations and guidelines.
- Experience with QMS implementation, audits, and deviation management.
- Strong attention to detail and excellent documentation skills.
- Ability to work effectively in a hybrid environment, collaborating with manufacturing, R&D, and regulatory teams.
Benefits
- Competitive annual salary and performance-based bonus.
- Hybrid working model offering flexibility.
- Comprehensive health insurance, including dental and optical cover.
- Company pension scheme.
- Support for professional development, including relevant certifications and training.