Qualified Person and Responsible Person - UK

Company DescriptionAt 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 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. Job DescriptionWe 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 documentationHold 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 license2. Training and Competency ManagementImplement and maintain GDP training programs for all personnel involved in medicinal product distributionEnsure employees receive appropriate GDP training and remain up to date with regulatory requirementsInform and train team members on changes in GDP regulations and quality systems3. GDP Operational OversightThe RP has full responsibility for:Authorizing all quality-related activities and recordsCoordinating product recalls or supporting recalls initiated by the Marketing Authorization Holder (MAH)Managing distribution-related deviationsManaging customer complaintsBeing available 24/7 for transport-related complaints and deviationsApproving suppliers, customers, and outsourced/subcontracted activities related to distributionManaging 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 stockReporting potential medicinal product shortages to the Dutch national portalEnsuring implementation of any additional legal requirements applicable to specific products4. Falsified Medicines Directive (FMD) ResponsibilitiesSupport implementation of Falsified Medicines Directive requirementsEnsure robust procedures are in place to identify and manage actual or potential falsified medicines within the supply chainEnsure compliance with applicable FMD requirements5. Delegation and Deputy ManagementMaintain records of all delegated responsibilitiesDocument what was delegated, to whom, and the duration of delegation where applicableSummary of RP AccountabilitiesThe RP is accountable for:GDP compliance and maintenance of the distribution licenceQMS oversightTraining and competency managementDeviations, complaints, recalls, and CAPA managementSupplier, customer, and contractor qualification/approvalManagement of returned, recalled, rejected, and falsified productsShortage reportingFMD complianceDocumentation of delegated responsibilitiesQualificationsEducation & Experience:Master Degree in Pharmacy, Pharmaceutical Chemistry, Life Sciences or related fieldEligible to act as a Qualified Person under applicable UK/EU regulationsSignificant Quality Assurance experience in pharmaceutical industryAdditional InformationKey Skills & Competencies:GMP/GDP expertise Strong auditing and compliance knowledge Analytical decision making Stakeholder management Excellent communication skills SummaryType: Full-timeFunction: Quality AssuranceExperience level: Mid-Senior LevelIndustry: Pharmaceuticals