Qualified Person and Responsible Person

Company Description 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 for their community and every community. Diversity, Equity & Inclusion
dy’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.

  Job Description 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)
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 distribution-related deviations

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 CAPAsAuthorizing 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
4. Falsified Medicines Directive (FMD) Responsibilities 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 licenceQMS 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 reportingFMD compliance

Documentation of delegated responsibilities

Qualifications

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

Additional Information Key Skills &

Competencies:

GMP/GDP expertise Strong auditing and compliance knowledge Analytical decision making Stakeholder management Excellent communication skills Summary Type:
Full-time Function:
Quality Assurance Experience level:
Mid-Senior Level Industry: Pharmaceuticals