Senior Quality Assurance Specialist

BioTalent; Oxford; On-site; GBP 40,000 - 60,000; Full time

Job summary

A global pharmaceutical organization in the UK seeks a Senior QA Specialist responsible for maintaining compliance with GMP regulations and internal quality standards. The role involves overseeing Quality Systems, leading audits, and ensuring product quality. Candidates should have a degree in a relevant field and at least 2 years of experience in Quality Systems within the pharmaceutical industry. Strong analytical skills and attention to detail are essential for success in this challenging environment.

Qualifications

• Minimum of 2 years of experience in Quality Systems within the pharmaceutical industry.
• Strong knowledge of GMP regulations and quality management systems.
• Experience in sterile manufacturing or highly regulated production environments is an asset.

Responsibilities

• Maintain and oversee Quality Systems in compliance with GMP and regulatory requirements.
• Review and approve batch records and quality-related reports.
• Lead internal audits and support regulatory inspections.

Skills

Strong analytical skills

Attention to detail

Effective communication

Education

Degree in Pharmacy, Chemistry, Pharmaceutical Chemistry, or Biology

Job description

BioTalent have partnered with a global pharmaceutical organization specializing in the development, manufacturing, and distribution of innovative diagnostic and therapeutic products used in highly regulated healthcare environments. With operations across multiple international markets, they are committed to delivering safe, high-quality medicines that support critical patient care pathways.

The organization operates complex manufacturing facilities and maintains rigorous quality standards to ensure compliance with international regulatory requirements and industry best practices. They are looking to welcome a Senior QA specialist on a permanent basis-this will also include shift work.

Position Summary

The Senior QA Specialist is responsible for maintaining and improving the Quality Management System (QMS) to ensure full compliance with GMP regulations and internal quality standards. This role supports manufacturing, laboratory, and distribution activities, ensuring the highest standards of product quality and patient safety.

Key Responsibilities

• Maintain and oversee Quality Systems (CAPA, deviations, change control, complaints, document control) in compliance with GMP and regulatory requirements.
• Review and approve batch records, validation documentation, protocols, and quality-related reports to ensure product release meets regulatory standards.
• Lead internal audits and support regulatory inspections, ensuring inspection readiness at all times.
• Investigate deviations and quality events, perform root cause analysis, and implement effective corrective and preventive actions.
• Collaborate cross-functionally with Manufacturing, QC, Regulatory Affairs, and Supply Chain to drive continuous improvement and ensure product quality and compliance.

Qualifications & Requirements

• Degree in Pharmacy, Chemistry, Pharmaceutical Chemistry, or Biology (required).
• Minimum of 2 years of experience in Quality Systems within the pharmaceutical industry.
• Strong knowledge of GMP regulations and quality management systems.
• Experience in sterile manufacturing or highly regulated production environments is an asset.
• Excellent analytical skills, strong attention to detail, and effective communication abilities.

Reach out for more information to: [e-mail]