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Senior Quality Assurance Officer
3 months ago
Senior Quality Assurance Officer
Are you an experienced and dedicated QA professional looking for a new challenge? If so, this role might be perfect for you. Joining a dynamic Quality Assurance team at a forward-thinking Contract Development and Manufacturing Organisation (CDMO) specializing in GMP manufacturing of ATMPs and related products, process development, and ancillary services.
Our client is a key player in the development of groundbreaking therapies for a diverse global market. They are pioneers in advanced therapy medicinal products, revolutionizing the treatment of life-threatening diseases.
Job Summary:
The Senior QA Officer will lead the charge in ensuring compliance with regulatory requirements and quality standards across the development, manufacturing, and distribution of advanced therapy medicinal products. Your responsibilities will encompass developing and implementing QA systems, managing quality records, and collaborating with cross-functional teams to drive continuous improvement.
Key responsibilities:
- Monitor and uphold compliance with regulatory frameworks (GMP, GDP).
- Develop and maintain quality management system documentation.
- Provide support to the QA Manager in handling quality records efficiently.
- Lead a team of QA professionals.
- Participate in risk assessments and devise strategies for risk mitigation.
- Identify areas for enhancement and implement quality control measures.
- Ensure effective communication with stakeholders.
- Verify suppliers' adherence to quality and compliance standards.
- Lead and engage in QMS initiatives.
Qualifications:
- BS or MS in a life science field or equivalent.
- Extensive QA experience in a GMP compliant pharmaceutical or biotechnology setting.
- Experience in conducting internal and external audits.
- Excellent communication skills and attention to detail.
- In-depth knowledge of regulations and standards for ATMPs.
This is an exciting opportunity to be part of a growing organization that values its employees. In addition to a competitive salary, we offer a comprehensive benefits package.
To Apply:
Candidates must have the right to work in the UK. Please refer to job reference (number removed) in all communications.
