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NEW IN: QA & Responsible Pharmacist Benelux

Position

JOB SUMMARY:

  • The Quality Assurance & Pharmacist Responsible is the key contact for all quality related activities for the Benelux office.
  • The Quality Assurance & Pharmacist Responsible for Benelux is specifically responsible, as the process owner, for GMP/GDP and ISO 13485 related systems in relation with the Quality System and performs the legal duties of “Responsible Pharmacist” listed on the Belgian Wholesale Dealer’s Licence (WDA (H)).
  • The Quality Assurance & Pharmacist Responsible is responsible for managing the Quality System within the Benelux, and ensuring it is in place and fully operational. The Quality Assurance System must comply with the requirements of the Belgian, Dutch and Grand Duchy of Luxembourg legislation, and should also meet regional and corporate QA requirements.
  • On behalf of the local legally responsible management, the Quality Assurance & Pharmacist Responsible is responsible to develop, implement and oversee QA System elements for Pharmaceutical Products and Medical Devices for the Benelux office:
    - Advertising & Medical Information
    - Corruption (legal)
    - Packaging Copy
    - Sales Force Activities
    - Customer Service Activities
  • As a member of the EAME Quality team, the Quality Assurance & Pharmacist Responsible for:
    - aligning local QA systems and procedures with the regional system
    - the design, operation, and monitoring of EAME-API systems and SOPs as designated periodically by the Associate Director of EAME Quality Assurance.
  • The Quality Assurance & Pharmacist Responsible is to provide QA support to the organization, by effectively communicating:
    - The local related QA requirements and issues to Local Management or to the EAME Quality Group.
    - Identify potential improvements and efficiencies.
  • The Quality Assurance & Pharmacist Responsible supports the daily handling of product medical/health complaints and adverse events.
  • The Quality Assurance & Pharmacist Responsible performs the role of Responsible Pharmacist for Pharmaceutical Information for the review of advertising and external communications.
  • KEY DUTIES AND RESPONSIBILITIES:

    1. Benelux Quality Assurance 80%
    1.1 Quality Management and Operations

  • Quality Systems: Local Quality Management System (QMS) responsible for:
    - Aligning QA and office SOPs with local requirements
    - Training BeNeLux staff on local SOPs
    - Review and follow-up to ensure compliance of processes: CAPA (Corrective and Preventive Actions), investigation and handling of deviations and significant complaints in Benelux.
    - Reporting significant quality issues to regional and global Quality management.
    - Documentation system: using the CORAL and Zinc to track approved documents
  • Staff training:
    - Induction training of new employees
    - Learning management System (LMS) responsible
  • Distribution:
    - Local product release and recall (local implementation and local communication with authorities)
    - Customer validation, order validations, Customer service oversight
    - Periodic customer revalidation
    - Management of at no charge goods and sample distribution
    - Distribution chain from 3PL (Third Party Logistic) to Customer & Returns from Customer to PL, liaise with third party distribution site used for distribution in Benelux Quality oversight of Sub-contractors (Local 3PL Management: Contracts, technical agreements + Audits)
    - Recall management if required.
  • Healthcare compliance:
    - Advise on advertising, external communications., sales force activities, events, meetings, contracts, Mdeon visum, CGR visum, promotion material review
    - Local compliance committee together with RA manager
    - Corruption (legal)
  • Audits and inspections
    - Hosting local MoH/NB/CVM inspections in Benelux
    - Internal audits and Allergan self-inspections
  • 1.2 Complaint handling 20%

  • Non-medical complaint handling (Argus system)
  • Assisting Product Surveillance with non-routine specific enquiries relating to Materiovigilance cases requiring local language communication:
    - Implement the Medical Device regulation in terms of distribution and safety, and assessing impact on the EAME processes
    - Interface with Benelux Authorities about requests related to Materiovigilance cases.
    - Oversight and routine audit of the Belgian third party contractor responsible for management and reporting to Product Surveillance of breast cases.
    - On request, support the MD manufacturer in drafting of timely reply to any specific MoH request on the sales and safety of products distributed by Allergan Benelux.
  • Supporting local Regulatory Affairs & Business groups by providing quality-related documents needed for local operations.
  • 2. EAM Quality Assurance 20%
    2.1 As a member of the EAME Quality team, the Quality Assurance & Pharmacist Responsible for Benelux is responsible for:

  • Implementing Quality systems and procedures in compliance with local requirements and regional and corporate requirements.
  • may participate in European activities such as audit, on behalf of other regional or Global QA requirements
  • Takes part to EAME-API Internal audits
  • Investigating and reporting significant non-conformities or potential significant non-conformities to the Associate Director of EAME QA and issuing “Rapid Alert” reports when required in accordance with local, regional and global SOPs.
  • INTERNAL AND EXTERNAL RELATIONSHIPS

    Allergan Internal - Sharing Information/advising

    BeNeLux

  • Responsible Management
  • Customer service
  • Commercial Teams
  • Regulatory affairs (support)
  • Non BeNeLux

  • EAMQA & Global QA
  • Manufacturing sites
  • Product Surveillance (Medical Devices)
  • EAM Healthcare Compliance, Pharmacovigilance and Medical Information
  • EAM Regulatory Affairs,.
  • External - Sharing Information/influencing

  • EAM Third Party Logistics
  • EAM Distributors
  • EAM Third Party Manufacturers
  • Local Health Authorities Inspection ( MoH and NB) in Benelux
  • External customers and consumers
  • Profile

    Essential Experience

  • Industrial Pharmacist eligible to perform role of GDP Responsible and Responsible Pharmacist for publicity.
  • Fluent English, Flemish and French languages
  • Desired experience

  • Ability to handle time pressure and high workload
  • Over 3 years of post-qualification experience
  • Company

    OUR CLIENT:

    Our client, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Our client is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.
    Our client markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.

    Our Client’s success is powered by more than 18,000 global colleagues’ commitment to being Bold for Life. Together, they build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.

    With commercial operations in approximately 100 countries, Our client is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives

    Contact

    Claudine Lachman