Job Title:Quality Assurance (QA) Specialist – Sterile Manufacturing (Vaccines)

Location:Watford, UK

Employment Type:Full-Time, On-Site (5 days per week)

Client Overview:

Our client, a leading sterile manufacturing facility in Watford, specialises in producing vaccines for infectious diseases, ensuring compliance with the highest standards of safety and efficacy. We are seeking an experienced Quality Assurance Specialist to ensure the production of vaccines adheres to rigorous regulatory and quality standards.

Role Overview:

The Quality Assurance Specialist will ensure vaccine manufacturing processes comply with Good Manufacturing Practices (GMP) and regulatory standards. You will oversee sterility assurance, review batch records, conduct audits, and manage deviations, directly contributing to the quality and safety of vaccines.

Key Responsibilities:

• 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 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 (CAPAs), and conduct root-cause analysis.
• Documentation & Regulatory Support:Maintain accurate documentation and support regulatory inspections (MHRA, FDA).
• Cross-Functional Collaboration:Work with production, R&D, and quality teams to ensure consistent application of quality standards.
• Training & Compliance:Train staff on GMP, sterile handling, and vaccine-specific regulatory requirements.
• Customer Complaint Analysis:Analyse quality trends and customer complaints related to vaccine safety and efficacy.

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.
• Communication:Strong verbal and written communication skills for documentation and client interaction.

Benefits of the Role:

• Competitive salary and benefits with opportunities for career growth.
• Direct involvement in the production of vaccines that support global public health.
• A meaningful role in ensuring the safety and quality of life-saving vaccine products.
• 26 days annual leave