Qualified Person

Qualified Person, supporting EU QP certification and release of both PGS and non PGS manufactured supplies.
The function serves to conduct EU QP batch certification and inventory release activities in accordance with EU GMP and the product marketing authorization. In addition, the QP will support those arrangements to alleviate drug shortage, including management of unlicensed supplies and exemptions provided by the BOH.
The QP will furthermore support the licensing requirements of the MIA (As identified and declared), including adherence, maintenance and development of the associated Quality Management System, continual professional development in associated dosage forms certified and BOH inspections and enquiries.

Requirements as per Annex 16:
• Eligible to act as a European Qualified Person, certifying products in compliance with 2001/83/EC, 2003/94/EC and Annex 16, with relevant experience in Sterile Injectable dosage form manufacture and testing
• Execute drug product batch certification and release functions in compliance with 2001/93/EC, 2003/94/EC, Annex 16, commercial tender and specials supply as required.
• Support those arrangements to alleviate drug shortage, including management of unlicensed supplies and exemptions provided by the BOH.
• Review of batch manufacturing records and other documentation associated with QC release in conjunction with QA Officers. Checking that batch manufacturing records comply with registered details and EU GMP standards. Investigating any differences or issues found upon review of the batch manufacturing records and rectifying problems in conjunction with relevant sites and personnel.
• Assists in the resolution of supply chain issues, such as product shortages, competent authority notifications and represents site at senior management meetings (as required)
• Work in partnership with internal stakeholder and functional groups supporting supply to market
• Provides support for global manufacturing sites and Pfizer internal departments (regulatory, operations etc)
• Liaise directly with Regulatory Agencies as required. Assisting in the preparation for and hosting of regulatory agency inspections, coordinates responses and ensures commitments are maintained.
• Executes assigned internal self-inspections, Quality Risk Management program, external audits, visits and assigned activities within the vendor management program.
• Issues QP Declarations of GMP compliance.
• Reviews, feedback and approves APQR documents.
• Develops and agrees both global and local quality agreements with vendors as needed.
• Co-ordinates any external tests by third parties whilst ensuring that they are performed in accordance with GLP/GMP guidelines, standards of Pfizer and the European Pharmacopoeias and USP recommendations
• Providing leadership in European regulations ensuring GMP knowledge of self and others within both the QA team and site is developed and applied.
• Maintain CPD in conformance with agreed plans and contributes to the sites training program (as required)
• Represents Pfizer in outside global technical groups and where required presents papers at external meetings.
• Provides support as required to routine departmental release requirements, covers other QPs when absent from the office in the execution of both QP duties and QA management.
• Implements and maintains assigned systems relative to Quality such as Procedures, Technical agreements, Validation, Change Control, Exception Reports / Deviations, Complaints, Internal Audits, External Audits & visits, Good Distribution Practice and Recalls.
• Provide guidance in the identification of process improvements

Personal Skills and Essential requirements:
Provides clear, direct and timely verbal and written communication to stakeholders.
Able to plan, manage and communicate personal workload, prioritizing activities to support patient safety, compliance, business needs and continuity of supply. Able to perform functions with minimal direction from management.
Contributes to resolving Quality & Operational issues across the business and site without direction.
Able to function proactively within the business unit, working as a team player across a range of colleagues with a range knowledge and skill sets.
Execute and manage projects, as per role assignment. Clear starter-finisher, taking responsibility for own and team deliverables.
• Bachelor’s degree in a related scientific discipline with relevant experience
• Eligible to act as a European Qualified Person under Belgium license (PSC/PISPI), certifying products in compliance with 2001/83/EC, 2003/94/EC and Annex 16