Sterile Manufacturing Quality Assurance Specialist
1 month ago
Barrington James is seeking a skilled Quality Assurance Specialist to join our team in Watford, UK. This role will play a crucial part in ensuring the production of vaccines adheres to rigorous regulatory and quality standards.
Job DescriptionThis is a full-time position that involves overseeing sterility assurance, reviewing batch records, conducting audits, and managing deviations to directly contribute to the quality and safety of vaccines.
- Sterility Assurance & Environmental Monitoring: Ensure aseptic conditions and sterility are maintained throughout the vaccine manufacturing process.
- Batch Record Review: Review and approve batch records and associated documentation for compliance with Good Manufacturing Practices (GMP).
- Audits & Compliance Checks: Conduct regular audits of production processes, equipment, and facilities to ensure regulatory compliance.
- Deviation & CAPA Management: Investigate deviations, implement corrective actions, and conduct root-cause analysis.
The successful candidate will have excellent analytical and problem-solving skills, with the ability to work effectively in a fast-paced environment. They will be responsible for maintaining accurate documentation, supporting regulatory inspections, and training staff on GMP, sterile handling, and vaccine-specific regulatory requirements.
Requirements- Education: Bachelor's degree in Quality Assurance, Pharmaceutical Sciences, or a related field.
- Experience: At least 3 years of quality assurance experience in sterile manufacturing, ideally in vaccine production.
- Regulatory Knowledge: Strong understanding of GMP, MHRA, FDA regulations, and vaccine-specific requirements.
- Skills: Proficient in CAPA management, risk assessment, root-cause analysis, and quality management systems.
- Attention to Detail: Ability to work in high-stakes environments where sterility and precision are critical.
This role offers a competitive salary and benefits package, as well as opportunities for career growth and professional development. The successful candidate will have the opportunity to work directly in the production of vaccines that support global public health.
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