Quality Assurance Specialist
Posted 1 day ago by Planet Pharma
Negotiable
Undetermined
Undetermined
London Area, United Kingdom
Summary: The Quality Assurance Specialist will be responsible for overseeing external manufacturing quality activities for a global pharmaceutical organization. This role ensures compliance with regulatory and corporate quality requirements throughout the manufacturing, packaging, testing, and distribution processes. The specialist will lead QA vendor oversight and manage various quality assurance activities, including documentation review and regulatory inspections. Strong experience in pharmaceutical quality assurance and knowledge of cGMP regulations are essential for success in this position.
Key Responsibilities:
- Lead QA vendor oversight for external manufacturers and distributors
- Review and approve batch records (master and executed) to ensure GMP and registration compliance
- Manage change controls, including QA evaluation, approval, tracking and escalation
- Oversee deviations, CAPAs, OOS and complaint investigations in collaboration with contractors
- Review and approve contractor documentation, including validation protocols/reports and investigations
- Lead Annual Product Quality Review (APQR) assessments
- Draft and negotiate Quality Agreements
- Participate in internal inspections and external audits
- Support FDA, EMA and other Health Authority inspections
- Contribute to maintenance and continuous improvement of the Pharmaceutical Quality System
Key Skills:
- Degree in a scientific discipline
- 5+ years’ pharmaceutical Quality Assurance experience
- Strong knowledge of US/EU cGMP and GDP regulations
- Experience working with external manufacturing sites
- Experience supporting Health Authority inspections
- Strong analytical, communication and stakeholder management skills
Salary (Rate): undetermined
City: London Area
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
We are partnering with a global pharmaceutical organisation seeking an experienced Quality Assurance Specialist to oversee external manufacturing quality activities across commercial bulk and finished drug products. This role is central to ensuring products are manufactured, packaged, tested, released and distributed in full compliance with global regulatory and corporate quality requirements.
Key Responsibilities
- Lead QA vendor oversight for external manufacturers and distributors
- Review and approve batch records (master and executed) to ensure GMP and registration compliance
- Manage change controls , including QA evaluation, approval, tracking and escalation
- Oversee deviations, CAPAs, OOS and complaint investigations in collaboration with contractors
- Review and approve contractor documentation , including validation protocols/reports and investigations
- Lead Annual Product Quality Review (APQR) assessments
- Draft and negotiate Quality Agreements
- Participate in internal inspections and external audits
- Support FDA, EMA and other Health Authority inspections
- Contribute to maintenance and continuous improvement of the Pharmaceutical Quality System
Experience Required
- Degree in a scientific discipline
- 5+ years’ pharmaceutical Quality Assurance experience
- Strong knowledge of US/EU cGMP and GDP regulations
- Experience working with external manufacturing sites
- Experience supporting Health Authority inspections
- Strong analytical, communication and stakeholder management skills
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
www.planet-pharma.com