Not specified; not specified; flexible benefits py...
Hybrid
Proven experience in pharmaceutical auditing
Extensive knowledge of global gxp guidelines
Expertise in capa management and root cause analysis
Mundipharma is seeking an experienced R&D Quality Assurance Lead Advisor with expertise in Good Clinical Practice (GCP) for a hybrid position in Cambridge, UK. The role involves managing audit schedules, providing QA guidance, and ensuring compliance with global standards in the pharmaceutical industry
Job Summary
The role involves planning and executing GxP audits including internal, vendor, and investigational site audits.
Candidates will provide expert QA guidance ensuring adherence to global standards and best practices for patient treatments.
The position offers a flexible benefits package and opportunities for learning and development within an inclusive work environment.
Matching Summary
Match Score: 85
Mundipharma is seeking an experienced R&D Quality Assurance Lead Advisor with expertise in Good Clinical Practice (GCP) for a hybrid position in Cambridge, UK. The role involves managing audit schedules, providing QA guidance, and ensuring compliance with global standards in the pharmaceutical industry.
Salary
Not specified; Not specified; Flexible benefits package included
Skills & Requirements
Must-have
Proven experience in pharmaceutical auditing
Extensive knowledge of Global GxP guidelines
Expertise in CAPA management and root cause analysis
Experience supporting regulatory inspections
Strong understanding of EU CTD format
Nice-to-have
Ability to critique technical information
Effective communication across all levels
Collaborative cross-functional teamwork
Proficient in Microsoft Office tools
Key Requirements
Scientific degree in Pharmacy, Chemistry, Biology, or Engineering
Extensive experience in GCP auditing within the Pharmaceutical Industry
6-month initial Fixed Term Contract with potential extension