Emplois actuels liés à QA Csc Associate - Beerse - Johnson & Johnson

Our department QA-CSC is responsible for the release and certification of Investigational Medicinal Products used in worldwide clinical trials guaranteeing product quality and compliance with applicable regulations.

The QA CSC Operations Beerse sub team supports the clinical manufacturing activities in Beerse (solids, parenterals, liquids, packaging & labeling) and the clinical release activities for Beerse manufactured and external products.

More specifically, the QA CSC Operations team is looking for a QA CSC associate to join the team supporting the packaging & labelling activities in Beerse.

As QA-CSC associate, you will support the clinical release and quality oversight process of IMPs (Chemical and Biological compounds as well as Vaccines) used in worldwide clinical trials so that patient safety and compliance with applicable regulations are warranted.
- Ensure timely review of quality records such as batch record and confirmation of clinical trial material in order to support a reliable supply chain.
- Support the operational quality performance by participating in different quality review meetings.
- Ensure that deviations and complaints are timely and properly investigated such that the internal and external customer expectations are met.
- Ensure that adequate CAPA’s are defined for investigations with potential product quality impact.
- Ensure that all changes that may have an impact on quality, compliance or registration are evaluated to execute adequate control, documentation, validation and qualification.
- Support in-depth investigations by providing technical, quality and compliance expertise.
- Support the quality oversight process of the operational activities by ensuring QA review and approval of GMP documentation.
- Support the in-house check rounds to verify the GMP compliance within the functional areas and support in preparation and execution of internal and external inspections.
- Continuously challenge the status quo and support the development and implementation of breakthrough innovative initiatives that deliver sustainable improvement in organizational, quality and compliance performance.
- Work as One team with Quality and Clinical Supply Chain partners to ensure timely release and certification of clinical trial material in support of a reliable supply chain.

**Qualifications**:

- University degree, scientific orientation (pharmaceutical, chemical, or biological sciences) with at least 2 years cross functional experience in the pharmaceutical industry.
- Experience in pharmaceutical supply chain and/or Quality Assurance is an asset.
- Demonstrated ability to work independently while staying connected with key stakeholders.
- Operational Quality and/or Production related expertise is an asset.
- Product development expertise is an asset.
- Ability to quickly assimilate new technologies and product knowledge, perform risk assessment and develop action plans.
- In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures.
- Understands the business implications regarding quality positions and decisions.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.