Position Purpose

The Pharmaceutical Affairs Officer / Manager is responsible for managing and overseeing all Quality Assurance (QA) and Regulatory Affairs (RA) activities within the organization and may act as Responsible Person (RP) in Belgium in accordance with applicable legislation. We are seeking a full-time employee; however, an 80% position may be considered for the right candidate.

Legal Requirements – Responsible Person (RP)

The position holder must be eligible to act as Responsible Person in Belgium in accordance with Article 95 §2 of the Royal Decree of 14 December 2006 on medicinal products for human use.

The RP must hold one of the following legally recognized diplomas:

• Pharmacist / Master in Pharmaceutical Sciences
• Medical Doctor / Master in Medicine
• Veterinarian / Master in Veterinary Medicine
• Chemist / Master in Chemistry
• Biologist / Master in Biology
• Biomedical Scientist / Master in Biomedical Sciences
• Bioengineer / Master in Bioengineering Sciences
• Or be legally exempt in accordance with the applicable legislation

Key Responsibilities

1. Regulatory Affairs (RA)

• Follow-up of Parallel import cases in Belgium and possible supply chain impact
• Application and follow-up of Certificates of Pharmaceutical Product (CPP)
• Maintaining and updating notifications to FAVV/AFSCA
• RA–PV interaction:
  • Safety Variations
  • PSUR planning and archiving
  • RMP archiving
  • Artwork updates (medicinal products as well as baby milks)

2. Quality Assurance (QA)

• General management of the Quality Management System
• Batch release (GDP)
• Recondition management
• Management of Non-Conformities (NC) and Deviations
• Change Controls & CAPA management
• Self-inspection management
• Management of narcotic products
• Reconciliation of different Quality Management System aspects
• Updating Local SOPs and FORMs/ documentation and keeping them up-to-date to corporate and/or (local) regulatory standards
• Complaint management:
• Incl. Follow-up of logistic complaints of customer service
• Incl. PV complaint reconciliation
• Monthly KPI reporting
• Yearly KPI meeting
• Point of contact for recall
• Client authorization management
• Supply qualification management
• Destruction management
• Returns management
• FMD follow-up
• Point of contact for LSP/3PL
• Training Management of QA-related procedures

Authority

• Acting as Responsible Person in accordance with Belgian legislation
• (GDP) Batch release
• Approval of quality documentation
• Support during internal and external audits
• Contact person for competent authorities (for QA)

Reporting Line

The Pharmaceutical Affairs Officer / Manager reports to the Head of Pharmaceutical Affairs and acts as the central point of contact for QA and RP-related matters to the Health Authorities.

Other Skills

• Languages: Dutch, French, English
• Strong organizational skills with a high level of attention to detail
• Pragmatic and solution-oriented mindset
• Dynamic, proactive and flexible
• Collaborative team player
• Ability to work efficiently in a structured and results-oriented manner

What We Offer

• A broad role beyond RA and QA, offering exposure to multiple aspects of the business rather than a narrow focus, where an out-of-the-box thinking is encouraged
• The opportunity to take ownership and contribute across a range of activities
• The chance to join a well-established, family-owned international pharmaceutical group with a strong presence across Europe and worldwide (see our website for more information: https://www.menarini.be/)
• A collaborative, team-oriented working environment
• An attractive and competitive salary and remuneration package

If you are interested in this position or would like more information, please fill out the online form below.