Do you have a strong quality mindset and a passion for excellence in the pharmaceutical industry?
Are you fluent in both Dutch and English?
Would you like to make an impact in a dynamic, family-owned company based in Belgium?
Then Will-Pharma could be the right place for you!
We are currently looking for a QA Manager (industrial pharmacist registered as QP)
(Wavre)
In this key role, you will contribute to safeguarding product quality and patient safety. Together with your colleagues, you will strengthen our Quality Management System and drive continuous improvement across the organization.
As QA Manager, you will act as the primary point of contact for all quality-related matters, both internally and externally. You will represent the company during audits and inspections and ensure that our medicines and healthcare products consistently meet the highest GxP standards.
YOUR KEY RESPONSIBILITIES
Quality and compliance: medicinal products, food supplements, cosmetics
o Act as RP in the Netherlands, in accordance with Chapter 2.2 of the European Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01), as well as the Dutch Medicines Act and its amendments (01/07/2007)
* Act as deputy QP in absence of the principal Qualified Person for medicinal products according to DIRECTIVE 2001/83/EC relating to medicinal products for human use and Belgian Royal Decrees of 25/03/1964 and 14/12/2006
* Act as deputy RP in Belgium in absence of the principal Responsible person for GDP according to chapter 2.2 of European guidelines of 5 November 2013 on Good Distribution Practices of medicinal products for human use (2013/C 343/01) and Belgian Royal Decree of 14/12/2006
* Ensuring maintenance and continuous improvement of quality management system according to GxP principles and in line with applicable regulations
* Application of QMS processes and procedures; tracking of GDP related Key Performance Indicators
* Perform daily QA operational activities: release of products, deviations, complaints, CAPA, returns, change control, NCP, risk management
* Ensuring personnel is trained on GMP/GDP and the training system remains up-to-date
* Conducting internal audits
* Performing supplier and sub-contractors qualification and evaluation
* Plan and conduct supplier and sub-contractors audit in EU to ensure compliance with company quality standards and GxP
* Support continuous improvement projects as quality expert
* Maintain WDA and MIA up-to-date
Interface with Regulatory Affairs (Belgium & the Netherlands)
* Evaluate proposed changes (internal/external) from a quality perspective regarding feasibility and impact on existing products and processes
* Ensuring change control process is deployed correctly and in a timely manner
* Support new product introductions as quality expert
EDUCATION AND WORK EXPERIENCE REQUIREMENTS:
o Licensed industrial pharmacist registered as Qualified Person (QP) with the FAMHP
o Formal training in auditing practices
o Excellent proficiency in Dutch and English is required.
WHAT WE OFFER
o A full time permanent contract, day schedule (Monday to Friday)
o The opportunity to develop yourself and grow within the organization
o A competitive salary package, including various benefits such as company car with fuel/charging car, hospitalization insurance, group insurance, meal vouchers,…
o Working in a socially responsible organization committed to continuous improvement and employee well-being.
A key role within a passionate QA/RA team
WHAT YOU BRING TO THE TEAM
o Strong communication skills, with the ability to convey complex information clearly and to advocate effectively for quality standards.
o You are able to work independently, in an organized and flexible way while adapting quickly to evolving priorities and dynamic environments.
o You are enthusiastic and a true team player.
HOW TO APPLY
If you are enthusiastic and match the profile described above, we would be delighted to receive your application. Please send your cover letter and CV to hrbelux@willpharma.com