QA Lab Associate

il y a 18 heures

Beerse, Belgique Johnson & Johnson Temps plein

**Job Function**:
Quality
**Job Sub Function**:
Quality Assurance
**Job Category**:
Professional
**All Job Posting Locations**:
Beerse, Antwerp, Belgium

We are looking for an employee that is having a passion for quality and loves to operate in a very dynamic pharmaceutical production environment. We are looking for an employee that likes to work with people and connects easily with our different business partners.

At the J&J IM SC Beerse site, different product types are being produced and released such as Steriles, Liquids & Creams and Transdermals. The Beerse Site Quality Department ensures that all GMP activities of manufacturing, packaging, labelling, testing, release and distribution of Products at/from the Campus Belgium are carried out as required by GMP legislation.

Within this department, the QA Lab team is responsible to ensure compliance during the daily QC testing aspects in the lab. The QA lab team is also responsible for release of excipients and packaging materials for further processing.

As QA Associate within the QA Lab team, you guarantee product quality by supporting investigations of non-conformances within the QC labs. You will have quality oversight and support the investigation by connecting with all parties involved and documenting quality related decisions in a well-founded manner. You ensure that root cause analysis, impact analysis and corrective and preventive actions are thoroughly carried out and documented.

**Responsibilities**:
Together with your team you support the daily quality operations within the quality control area:

- Review and release of excipient and packaging materials.
- Ensure that deviations, CAPAs, Change Controls and trend reports are timely and properly investigated by providing quality, compliance and technical expertise such that the internal and external customer expectations are.
- Attend tier meetings within the QC Lab and QA Lab team.
- Prepare and attend QIP meetings.
- Perform check rounds in the QC laboratories and periodic witnessing of QC method execution.
- Establish and maintain strong working relationships with Business and Quality partners to ensure alignment of objectives and results and act as Quality Point of Contact.
- Support the quality oversight process of the operational activities by ensuring QA review and approval of GMP documentation.
- Ensure that deviations with potential impact on patient safety and/or product supply are properly escalated.
- Act as spokesperson during Health Authority inspections and customer audits.

**Job Qualifications**:

- University degree, scientific orientation (pharmaceutical, chemical or biological sciences/engineering).
- 2-5 years experience in Pharmaceutical Industry. Experience within QC is an asset.
- Demonstrated ability to work independently while staying connected with key stakeholders.
- Thorough knowledge of pharmaceutical legislation, in cGMP regulations (domestic & international), ICH guidelines, policies, standards and procedures
- Strong analytical thinking skills, solution oriented thinking and able to work in a flexible way under time pressure. Ability to make risk-based decision under time pressure.
- Excellent communicator, ability to building a network and create win-win solutions
- Understands the business implications regarding quality positions and decisions

**Closing Date**: Wednesday 27th of August 2025.

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