Qualified Person (QP)

The Qualified Person (QP) will be responsible for ensuring that each batch of medicinal product is manufactured and checked in compliance with applicable laws, EU/UK regulations, and Marketing Authorization requirements prior to release. The QP will act as the primary authority for quality, compliance, and batch certification, ensuring patient safety and regulatory adherence across UK/EU markets.Post approval of the QP application, the individual will formally act as the Qualified PersonAccountability Clusters & Major ActivitiesI. Manufacturing Oversight & ComplianceMonitor manufacturing of batches to ensure overall manufacturing compliance.Drive manufacturing processes as per:National laws of the respective countries, and/orEuropean Union regulations.Ensure full compliance with the requirements of the Marketing Authorization.II. Batch Specifications, Import & Product Release ManagementSchedule and manage overall specifications as described in the guidelines for each batch imported into the EU.Drive and monitor quantitative and qualitative analysis of products imported from outside the EU in accordance with Marketing Authorization requirements.Quantitative & Release ActivitiesReview and evaluate release of necessary certificates as per EU guidelines.Plan, implement, and track release of required reference retained samples for each batch.Monitor validation of manufacturing and quality control testing processes.Help resolve product issues for the UK/EU market by working with cross-functional teams for both:IH productsIL productsIII. Documentation, Registers & Record MaintenanceImplement and maintain Registers or equivalent documentation covering all operations.Implement and track certifications for product release or sale within the EU.Maintain records including but not limited to:Quality Management Review (QMR)Annual Product Review (APR)DeviationsCAPAsRisk AssessmentsChange ControlsSelf-InspectionsEvaluate validation of Quality Agreements with third parties in line with GMP compliance.IV. Quality Systems & Compliance GovernanceDrive, monitor, and control the company Quality System in compliance with regulatory and legal frameworks.Act as the single point of contact for:Quality issuesCompliance questionsProduct recallsMonitor, control, resolve, and track implementation of all:Corporate Quality PoliciesCompliance proceduresLocal regulatory requirementsPlan, drive, and track training of all affected employees on relevant SOPs and guidelines.Verify training effectiveness periodically.Drive development and maintenance of clear Quality SOPs for UK and Europe aligned with current guidelines.V. Management Advisory & Regulatory SurveillanceReview, evaluate, and guide management on manufacturing and quality factors affecting product quality and patient safety.Stay abreast of developments in:Legal environments affecting the companyEU and UK regulatory changesPlan, track, and present quality and regulatory issues, concerns, and developments to management in a timely manner.Support EURA to liaise with MHRA for:Manufacturing line approvalsProduct approvalsVI. QP Role ResponsibilityAct as Qualified Person for Cipla Holding B.V. post QP application approval.Required QualificationsMust be eligible to act as a Qualified Person under UK law (Directive 2001/83/EC).Typically holds a degree in:PharmacyChemistryBiologyor related discipline.Minimum 4–5 years’ experience as a Qualified Person.Extensive experience in pharmaceutical manufacturing and quality assurance.Must have experience working in large pharmaceutical organizations.Experience RequirementsAt least 4–5 years functioning in a formal QP role.Proven experience in GMP-regulated pharmaceutical environments.Experience with UK/EU regulatory authorities and inspections preferred.Skills & AttributesStrong understanding of GMP and pharmaceutical regulations.Excellent decision-making and problem-solving abilities.High attention to detail and strong professional integrity.Strong leadership, communication, and stakeholder management skills.Work EnvironmentPrimarily based at manufacturing site or corporate quality office.Works closely with:ProductionQuality AssuranceRegulatory AffairsSupply ChainMust-Haves4–5 years minimum as a Qualified PersonDegree in pharmacy, chemistry, biology, or related fieldEligibility as QP under UK lawStrong GMP and regulatory knowledgeExperience in large pharmaceutical companiesExtensive pharmaceutical manufacturing and QA experience

Created: 2026-01-18