Responsible Pharmacist & Qualified Person delegate; Benelux
Ensure operation in compliance with EU and National regulations and internal Quality System
Distribution and batch release
Our client is a world-leading consumer health company with a clear purpose to deliver better everyday health with humanity.
Their leading brands are built on science, innovation and human understanding and are trusted by millions of consumers globally. With a strong portfolio of brands and a positioning to play a vital role for people all around the world, in a growing sector and more relevant than ever.
In order to sustain their growth in BNL today, they are looking to extend their team in Quality. The joining QA Operations Manager will focus on RP responsibilities, work on traversal project to improve the processes & act as QP delegate.
As the successful QA Operations Manager, you will have the following responsibilities:
- Work with the Benelux Quality Lead to ensure compliance, product quality, audit/inspection management and readiness
- Take the full ownership on the RP responsibilities - mainly focus on NL at first
- Participate to the QP-certification of medicinal products.
- Oversight and supervise the Benelux QA Specialists in the operational activities:
- Batch Release dossier preparation
- Receipt, Storage and Returns
- Local Repacking
- Quality Complaints management
- Ensure oversight of Benelux Logistic Service Providers
- Act as liaison with manufacturing sites and CMO
- Participate with the Quality Lead to the supplier qualification activity and the review and approval of the Technical Terms of Supply and Quality Agreements.
- Ensure an efficient customer verification process
- Approve and follow up Benelux Change Controls
- Perform local review of annual Periodic Product Reviews
- Participate to the setup of Distribution Risk Assessments (DRA) for products supplied from the local warehouse to the end customers.
- Ensure oversight and support Independent Business Monitoring and Self-Inspections in full compliance
- Ensure local Quality deviation investigation (Root Cause Analysis), CAPA definition and execution.
- Follow up the deviation and CAPA lead-times.
- Integrate the local Product incident review Committee as appropriate and support of recall coordination when required.
- Support the QA team with the development and maintenance of procedures and work instructions.
- Act as Expert for specific Benelux GxP-processes and systems.
- Participate to Quality Councils. Support management reviews and KPI-reporting.
- Contribute to the Benelux Quality Plan (setup and execution).
As the successful QA Operations Manager, you will have the following requirements:
- Certified Industrial Pharmacist / Qualified Person / Responsible Person
- At least a Master degree in Pharmaceutical Sciences or related life science field
- Good understanding of GDP and GMP, pharmaceutical regulation
- A proven experience as a practising QP/RP
- Analytical mind, good attention to detail and problem-solving skills within a structured process
- Demonstrable time management skills and ability to multi-task in an ambiguous environment
- Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods
- Self-motivated and resilient
- Fluent in English & Dutch - French is consider as a strong asset
As the successful QA Operations Manager, you will:
- Have an attractive complete salary package in line with your experience (Bonus, Net allowances, Company car, etc.)
- Join a fast moving & growing environment where you will be part of the future of the organisation
- Integrate a strong team driven by expertise & qualitative work
- Have growing & personal development opportunities