QA Associate Distribution Center
il y a 2 semaines
Johnson & Johnson is recruiting for a QA Associate supporting the Distribution Center, located in Beerse, Belgium.
The distribution center is a key player in multiple supply chains, acting as European DC for controlled substances, Worldwide Distribution Center supporting clinical trials and supporting our CAR-T manufacturing sites in Ghent.
In this role, you will play a critical part in ensuring compliance of both distribution and manufacturing activities, including repack and labeling and taking an active role in managing our QMS-associated processes. You will be working closely with several departments, including our operational team, Clinical Supply Chain, CAR-T, CQ EMEA and several others on a local and regional level.
You will also support investigations, root cause analysis, and change controls. Additionally, you will have the opportunity to lead projects linked to continuous improvement, increased compliance, and efficiency.
Key Responsibilities:
- Support in-depth investigations by providing quality and compliance expertise and ensuring the correct root cause and corrective actions are determined
- Perform batch record review related to repack activities completed at DC Beerse
- Act as QA representative in local and regional projects and ensure actions are properly documented in Change Controls
- Own the QMS processes applicable to DC Beerse team
- Maintain oversight of the QA specific parameters related to training, investigations, CAPA, change controls and audit follow-up
- Create and lead projects related to continuous improvement, increased compliance and/or efficiency
- Support the preparation, execution and follow-up of inspections and audits
- Establish and maintain effective working relationships with the different business partners to ensure the implementation and maintenance of harmonized and robust processes
- Support the operational and QA departments by providing coaching and/or training
**Qualifications**:
Experience and Skills:
Required:
- A Master's degree in Pharmaceutical sciences, Biomedical sciences or similar scientific studies is required.
- Fluent in Dutch and English
- Motivated and eager to learn
- Strong analytical thinking and decision-making skills
- Works well in a team
- Able to work in a dynamic organisation and identifying the right priorities
- Strong interpersonal skills
Preferred:
- Experience with Comet, TruVault, Summit, QMS-processes
- Experience working in a GMP or GDP-regulated environment
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