QA Release responsible Transdermals

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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Job Description:

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

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.

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.

As a QA Release responsible Transdermals 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:

You are responsible for the daily quality operations within the Transdermals manufacturing area and take up additional/back-up responsibilities within the QA team:

• Batch release of the products
• Ensure that deviations CAPAs Change Controls and trend reports are timely and properly investigated by providing quality and compliance expertise
• Assure compliance with the marketing authorization and Good Manufacturing Practices
• Act as spokesperson during Health Authority inspections and customer audits.
• Perform check rounds and periodic witnessing of operational processes
• 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 quality oversight on projects.
• Ensure that deviations with potential impact on patient safety and/or product supply are properly escalated.

Job Qualifications:

• University degree scientific orientation (pharmaceutical chemical or biological sciences/engineering)
• 2-5 years experience in a Pharmaceutical Industry.
• You have a quality-driven mindset. You are familiar with the GMP legislation and deliver accurate and precise work.
• You can demonstrate the ability to work independently while staying connected with key stakeholders.
• You can work well in a team and maintain an open and constructive dialogue with the various partners. You can deal with time pressure and changing priorities. You are able to make risk-based decision under time pressure.
• You strive to deliver results and progress. You have a pro-active attitude and are familiar with risk management principles.
• You are analytical and problem solving. You are constantly looking for continuous improvement
• You have a thorough knowledge of pharmaceutical legislation in cGMP regulations (domestic & international) ICH guidelines policies and procedures
• You are an excellent communicator able to build a network and create win-win solutions
• You understand the business implications regarding quality positions and decisions

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