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.
• Drive and monitor quantitative and qualitative analysis of products imported from outside the EU in accordance with Marketing Authorization requirements.

Quantitative & Release Activities

• 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