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Quality Assurance Specialist
- sunderland, tyne and wear, SR1 1AA, United Kingdom
- Permanent·On-site
- Full time
- £35,000 - £35,000 Per Annum
Job Description
About the Role
Our client is seeking a detail-oriented Quality Assurance Specialist to join their established manufacturing facility in Sunderland . This critical role ensures that all pharmaceutical products manufactured meet the highest standards of quality, safety, and efficacy, adhering strictly to regulatory requirements. You will be responsible for implementing and maintaining quality management systems, conducting audits, and investigating deviations to uphold compliance. This is a foundational role within our client's operations, ensuring the integrity and reliability of their Pharmaceutical products and contributing to patient safety within the Tyne and Wear region.
Key Responsibilities
- Implement and maintain the company's Quality Management System (QMS) in accordance with regulatory standards (e.g., GMP, ISO).
- Conduct internal audits of manufacturing processes, documentation, and facilities to ensure compliance.
- Investigate quality deviations, non-conformances, and customer complaints, determining root causes and implementing corrective and preventive actions (CAPAs).
- Review and approve batch records, validation reports, and other quality-related documentation.
- Participate in external audits conducted by regulatory agencies and customers.
Requirements
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
- Minimum of 2 years of experience in a Quality Assurance or Quality Control role within the Pharmaceutical industry.
- Thorough understanding of Good Manufacturing Practices (GMP) and other relevant regulatory guidelines.
- Experience with document control, change control, deviation management, and CAPA systems.
- Strong analytical, problem-solving, and auditing skills, with excellent attention to detail.
Benefits
- Competitive salary and potential for annual performance bonuses.
- Comprehensive benefits package including health, dental, and vision insurance.
- Company pension scheme and life insurance.
- Opportunities for specialized training and professional development in quality assurance.
- A stable and supportive working environment within a reputable Pharmaceutical company in Sunderland .