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