QA Release Responsible Incoming Materials & EU Release

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Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Beerse, Antwerp, Belgium

Job Description:

QA Release Responsible Incoming Materials & EU Release

Job Description

We are looking for a quality-driven professional who thrives in a dynamic pharmaceutical manufacturing environment and is passionate about ensuring patient safety, product quality and regulatory compliance.

You enjoy collaborating with cross-functional teams, building strong partnerships and making sound quality decisions in a fast-paced setting.

At the J&J Innovative Medicines Supply Chain (IM SC) Beerse site, a wide range of pharmaceutical products are manufactured, packaged and distributed worldwide.

The Site Quality organization ensures that all GMP-related activities are performed in compliance with applicable regulatory requirements and company standards.

Within the Quality organization, the QA Release team is responsible for the quality oversight and release of incoming materials, including raw materials and packaging materials, as well as supporting EU Batch Release activities for finished medicinal products.

As a QA Release Responsible, you play a critical role in safeguarding product quality and maintaining continuity of supply.

You are responsible for the timely and compliant release of raw materials, excipients and packaging materials for manufacturing operations.

In addition, you support EU Release activities by ensuring that all quality requirements have been fulfilled before products are certified and released to the market.

You provide quality oversight, assess quality-related events, and collaborate closely with QC, planning,....

Through risk-based decision making and strong stakeholder engagement, you ensure compliance while balancing patient safety and business continuity.

Key Responsibilities


* Provide QA oversight for Deviations, CAPAs, Change Controls, Complaints and trend investigations related to incoming materials or batch release activities.


* Ensure investigations are conducted in a timely, scientific and compliant manner and effectively address root causes.


* Revie...