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