QA Release Responsible Parenterals

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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.
• Collaboration and Stakeholder Engagement: Foster and maintain effective working relationships with internal teams, business partners, and external collaborators, ensuring alignment with quality objectives and deliverables.
• Act as Core Team Member in projects
• Act as spokesperson during Health Authority inspections and customer audits.
• With focus on Quality activities, develop and foster an environment of innovative thinking through e.g. benchmarking, training, participating in industry fora. Continuously challenge the status quo by identifying opportunities for continuous improvement. Drive the development and implementation of innovative initiatives that deliver sustainable improvement in organizational, quality and compliance performance.

Job Qualifications:

• University degree, scientific orientation (pharmaceutical, chemical or biological sciences/engineering)
• Experience in Pharmaceutical industry and knowledge on Aseptic Processing is preferred.
• In depth understanding of pharmaceutical production (manufacturing and packaging) and the specific technologies that are being applied, qualification, validation, testing, release
• Thorough knowledge of pharmaceutical legislation, in cGMP regulations, ICH guidelines, policies, standards and procedures
• Strong analytical thinking, risk assessment, managerial and leadership skills
• Ability to provide operational leadership to meet business objectives in a highly dynamic business environment
• Excellent communicator, ability to build a network and create win-win solutions
• Understands the business implications regarding quality positions and decisions