Qualified Person (QP)
1 day ago
City of London
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 Person Accountability Clusters & Major Activities I. Manufacturing Oversight & Compliance • Monitor manufacturing of batches to ensure overall manufacturing compliance., • Drive manufacturing processes as per:, • National laws of the respective countries, and/or, • European Union regulations., • Ensure full compliance with the requirements of the Marketing Authorization. II. Batch Specifications, Import & Product Release Management • Schedule and manage overall specifications as described in the guidelines for each batch imported into the EU., • Review 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 products, • IL products III. Documentation, Registers & Record Maintenance • Implement 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), • Deviations, • CAPAs, • Risk Assessments, • Change Controls, • Self-Inspections, • Evaluate validation of Quality Agreements with third parties in line with GMP compliance. IV. Quality Systems & Compliance Governance • Drive, monitor, and control the company Quality System in compliance with regulatory and legal frameworks., • Act as the single point of contact for:, • Quality issues, • Compliance questions, • Product recalls, • Monitor, control, resolve, and track implementation of all:, • Corporate Quality Policies, • Compliance procedures, • Local regulatory requirements, • Plan, 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 Surveillance • Review, evaluate, and guide management on manufacturing and quality factors affecting product quality and patient safety., • Stay abreast of developments in:, • Legal environments affecting the company, • EU and UK regulatory changes, • Plan, 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 approvals, • Product approvals VI. QP Role Responsibility • Act as Qualified Person for Cipla Holding B.V. post QP application approval. Required Qualifications • Must be eligible to act as a Qualified Person under UK law (Directive 2001/83/EC)., • Typically holds a degree in:, • Pharmacy, • Chemistry, • Biology, • or 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 Requirements • At 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 & Attributes • Strong 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 Environment • Primarily based at manufacturing site or corporate quality office., • Works closely with:, • Production, • Quality Assurance, • Regulatory Affairs, • Supply Chain Must-Haves • 4–5 years minimum as a Qualified Person, • Degree in pharmacy, chemistry, biology, or related field, • Eligibility as QP under UK law, • Strong GMP and regulatory knowledge, • Experience in large pharmaceutical companies, • Extensive pharmaceutical manufacturing and QA experience