Qualified Person and Responsible Person - UK
- Full-time
- Job Family: Quality
- Sub Job Family: Quality Assurance
- Preferred type of working: On-Premise
- Years of Experience: 3 - 6
- Business unit: EUG
At Dr. Reddy's "Good Health Can't Wait"
By joining Dr. Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference fortheircommunity andeverycommunity.
Diversity, Equity & Inclusion
At Dr. Reddy’s, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background.
We are seeking aResponsible 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)
- Implement and maintain the GDP Quality Management System and related documentation
- Hold ultimate responsibility for products manufactured in Europe and stored/transported under the WDA (Wholesale Distribution Authorization)
- Ensure compliance necessary to obtain and maintain the distribution license
2. Training and Competency Management
- Implement and maintain GDP training programs for all personnel involved in medicinal product distribution
- Ensure employees receive appropriate GDP training and remain up to date with regulatory requirements
- Inform and train team members on changes in GDP regulations and quality systems
3. GDP Operational Oversight
The RP has full responsibility for:
- Authorizing all quality-related activities and records
- Coordinating product recalls or supporting recalls initiated by the Marketing Authorization Holder (MAH)
- Managing customer complaints
- Being available 24/7 for transport-related complaints and deviations
- Approving suppliers, customers, and outsourced/subcontracted activities related to distribution
- Managing the self-inspection program to verify GDP compliance and implementation of CAPAs
- Authorizing the handling of returned, rejected, recalled, and falsified medicinal products, including decisions on returning products to saleable stock
- Reporting potential medicinal product shortages to the Dutch national portal
- Ensuring implementation of any additional legal requirements applicable to specific products
- Support implementation of Falsified Medicines Directive requirements
- Ensure robust procedures are in place to identify and manage actual or potential falsified medicines within the supply chain
- Ensure compliance with applicable FMD requirements
5. Delegation and Deputy Management
- Maintain records of all delegated responsibilities
- Document what was delegated, to whom, and the duration of delegation where applicable
Summary of RP Accountabilities
The RP is accountable for:
- GDP compliance and maintenance of the distribution licence
- QMS oversight
- Training and competency management
- Deviations, complaints, recalls, and CAPA management
- Supplier, customer, and contractor qualification/approval
- Management of returned, recalled, rejected and falsified products
- Shortage reporting
- FMD compliance
- Documentation of delegated responsibilities
Education & Experience:
MasterDegree 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
GMP/GDP expertise
Strong auditing and compliance knowledge
Qualified Person and Responsible Person - UK in Cambridge employer: Dr Reddy's Laboratories Limited
Dr. Reddy’s Laboratories Ltd. is an exceptional employer, offering a dynamic and entrepreneurial work culture that empowers employees to make a meaningful impact in the pharmaceutical industry. With a strong focus on employee growth and development, this role as a Commercial Manager provides opportunities for career acceleration and exposure to strategic decision-making within a globally recognised company. Located in the UK & Ireland, employees benefit from competitive compensation, a collaborative environment, and the chance to contribute to innovative healthcare solutions that truly matter.
Contact Details:
Dr Reddy's Laboratories Limited Recruitment Team
