Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2,000 employees across Europe, Asia, and the Americas.
Due to our constant growth, we are looking for a cQA Officer to support our projects in Belgium, with activities also covering the German market.
You will be responsible for
Fiscal Import & Product Release Activities
* Managing Fiscal Import activities for Belgium and Germany.
* Release of medicinal products for the Belgian and German markets, including reconciliation and reporting.
* Conducting Annual Product Quality Reviews (APQRs) for Belgium and Germany.
* Acting as back-up for critical activities such as field actions and recalls, and supporting distribution-related activities.
Quality Assurance Activities
* Coordinating with the Vantive Belgium SRL Qualified Person on:
* Administrative batch releases (file preparation, monthly release registers, reconciliation, and archiving).
* Annual Product Quality Reviews.
* Performing customer qualification and eligibility checks.
* Supporting First Code Activation and managing Quarantine, Hold, and Returned Goods reporting.
* Acting as Local Complaint Coordinator.
* Acting as Local Documentation Coordinator, including:
* Coordination of local implementation of corporate documentation.
* Authoring, publishing, and periodically reviewing SOPs.
* Acting as Client/CAPA initiator, investigator, or task assignee as required.
* Supporting the implementation of Field Actions.
* Supporting training planning and related reporting.
* Supporting supplier deviation management (SCAR) when needed.
* Supporting the maintenance and management of the document retention system.
Regulatory Affairs Activities
* Participating in Regulatory Affairs–related tasks as required.
About you
* Basic knowledge of pharmaceutical and medical device regulations.
* Scientific background or scientific knowledge.
* Strong administrative and project management skills.
* Ability to multitask, prioritize, and work independently.
* Strong interpersonal and communication skills.
* Proficiency with technical systems (e.g. word processing, spreadsheets, databases, online research tools).
* Fluency in English and French and/or Dutch.
* German language skills are considered an asset.
Next Steps
Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.
If there is a positive match, a technical interview with the Hiring Manager will be arranged.
In the case of a positive outcome following the Hiring Manager interview, the recruiter will contact you to discuss the next steps or our proposal.
Alternatively, if the outcome is negative, we will contact you to close the recruitment process.
Working at PQE Group
As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group offers the opportunity to work on international projects, enhance your skills, and collaborate with colleagues from all over the world.
If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.
Apply now and take the first step towards an amazing future with us.