QA Release Responsible Parenterals

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Beerse, Antwerp, Belgium

Job Description:

We are looking for an employee that has a passion for quality and loves to operate in a dynamic pharmaceutical production environment.

We are looking for an employee that likes to work with people, is connecting easily with our different business partners and wants to participate in the quality transformation through innovative solutions for the production site of the future.

Job Description:

At the J&J Innovative Medicine SC Beerse/Olen facility, various types of products are manufactured and released, including Steriles, Liquids & Creams, and Transdermals.

The Quality Department at the Beerse site is dedicated to ensuring that all Good Manufacturing Practice (GMP) activities related to manufacturing, packaging, labeling, testing, release, and distribution of products from the Campus Belgium adhere to GMP regulations.

Within this department, the QA Parenterals team focuses on the review and release of commercial parenteral products.

As a QA Associate Parenterals, you will conduct QA reviews of non-conformances and be responsible for the internal release of intermediates and finished products, ensuring compliance with all manufacturing and testing requirements.

Job Responsibilities:



* Release responsible: Release of intermediate and finished products, ensuring compliance with all manufacturing and testing requirements.


* Deviations: Ensure that deviations and complaints are promptly and thoroughly investigated, with particular attention to those that may affect patient safety or product supply.

Escalate issues that could have significant impacts on quality.


* CAPA Management: Ensure that appropriate corrective and preventive actions (CAPAs) are identified and implemented in response to investigations, especially those with potential impacts on product quality and patient safety.


* Inspection and Audit Support: Assist in the preparation, execution, and follow-up of internal and external inspections and audits to ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.


* Quality Oversight Participation: Contribute to the quality oversight programs by providing documented QA approval for GMP documentation and actively participating in quality review meetings to support operational activities.
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