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 Person.

Accountability Clusters & Major Activities

• 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.
• Batch Specifications, Import & Product Release Management
  • Schedule 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.
  • 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 and IL products.
• 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, Change Controls, and Self-Inspections.
  • Evaluate validation of Quality Agreements with third parties in line with GMP compliance.
• 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 and product recalls.
  • Monitor, control, resolve, and track implementation of all Corporate Quality Policies, compliance procedures, and 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.
• 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 and 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 and product approvals.
• 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, 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.
• Primarily based at manufacturing site or corporate quality office.
• Works closely with Production, Quality Assurance, Regulatory Affairs, and 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.