We are seeking a Responsible Person (RP) in our Quality Assurance team, to be based in person from our Cambridge, UK office and report to Head of Quality - UK. You will be accountable for ensuring that all activities related to the importation, storage, transportation, and distribution of medicinal products are conducted in compliance with applicable UK Good Distribution Practice (GDP) requirements, the Human Medicines Regulations 2012 (as amended), and other relevant regulatory obligations.
Responsibilities:
Quality Management System (QMS)
2. Training and Competency Management
3. GDP Operational Oversight
The RP has full responsibility for:
4. Falsified Medicines Directive (FMD) Responsibilities
5. Delegation and Deputy Management
Summary of RP Accountabilities
The RP is accountable for:
Education & Experience:
Master Degree in Pharmacy, Pharmaceutical Chemistry, Life Sciences or related field
Eligible to act as a Qualified Person under applicable UK/EU regulations
Significant Quality Assurance experience in pharmaceutical industry
Key Skills & Competencies:
GMP/GDP expertise
Strong auditing and compliance knowledge
Analytical decision making
Stakeholder management
Excellent communication skills
Qualified Person and Responsible Person - UK • Cambridge, England, United Kingdom
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