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NEW IN: QA & Responsible Pharmacist Benelux
- Advertising & Medical Information
- Corruption (legal)
- Packaging Copy
- Sales Force Activities
- Customer Service Activities
- 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 local related QA requirements and issues to Local Management or to the EAME Quality Group.
- Identify potential improvements and efficiencies.
KEY DUTIES AND RESPONSIBILITIES:
1. Benelux Quality Assurance 80%
1.1 Quality Management and Operations
- 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
- Induction training of new employees
- Learning management System (LMS) responsible
- 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.
- 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)
- Hosting local MoH/NB/CVM inspections in Benelux
- Internal audits and Allergan self-inspections
1.2 Complaint handling 20%
- 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.
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:
INTERNAL AND EXTERNAL RELATIONSHIPS
Allergan Internal - Sharing Information/advising
External - Sharing Information/influencing
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