2X QA Release Responsible (DAP)

Biopharma Careers

Antwerpen

Hybrid

EUR 60,000 - 80,000

Full time

11 days ago

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Job summary

Johnson & Johnson Beerse site seeks a QA Release Responsible for Device Assembly and Parenteral Packaging. The role ensures batch release, deviation handling, CAPA coordination, and regulatory compliance within a GMP environment.

You will collaborate with Operations, Quality, and cross-functional teams, maintain inspection readiness, and support Health Authority inspections and internal audits while acting as a Quality point of contact.

Qualifications

  • University degree in pharmaceutical, chemical, biological sciences, or engineering.
  • 2–5 years of pharmaceutical industry experience.
  • Fluent Dutch and English, both written and spoken.

Responsibilities

  • Release incoming half-finished and finished products in a timely manner.
  • Review investigations, deviations, CAPAs, change controls, and trend reports.
  • Provide QA oversight during investigations and issue resolution.
  • Ensure GMP compliance and regulatory alignment for products.
  • Act as QA spokesperson during Health Authority inspections and audits.
  • Maintain inspection readiness and quality oversight across operations.

Skills

Fluent Dutch
Fluent English

Education

University degree in Pharmaceutical/ Chemical/ Biological Sciences or Engineering

Job description

Johnson & JohnsonPosted October 16, 2026# 2X QA Release Responsible (DAP)Beerse, Belgium Full timeQualityNotify me about similar jobsView Full Job & Apply at Johnson & JohnsonJohnson & Johnson is the source of truth for this posting and owns the application process. We surface normalized context and market comparison you won't find on the original listing.## About this opportunityAt 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 jnj.com .As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.**Job Function:**Quality**Job Sub Function:**Quality Assurance**Job Category:**Professional**All Job Posting Locations:**Beerse, Antwerp, Belgium**Job Description:**Important Notice**There are currently two vacancies available for this position. We welcome applications from qualified candidates who are interested in joining our team and look forward to hearing from you!**We are searching for the best talent for a **QA Release Responsible – Device Assembly & Parenteral Packaging**.PurposeWe are looking for a QA Release Responsible to join the Quality organization at Johnson & Johnson Innovative Medicine in Beerse, Belgium.Do you enjoy working in a dynamic pharmaceutical manufacturing environment while helping ensure products meet the highest quality and compliance standards?The Quality Department supports all GMP activities related to manufacturing, packaging, labeling, testing, release, and distribution of products manufactured on the Belgium campus. In this role, you will provide Quality Assurance support for Device Assembly and Parenteral Packaging operations, including batch release activities, quality oversight of manufacturing processes, investigation management, and inspection readiness activities.You will work closely with Operations, Quality, and cross-functional partners to help ensure compliance with GMP requirements, marketing authorizations, and internal quality standards.You will be responsible forIn this role, you will provide Quality oversight for Device Assembly and Parenteral Packaging activities and support day-to-day quality operations within the area.Key responsibilities include:Releasing incoming half-finished products and assembled/finished products in a timely mannerReviewing and supporting investigations, deviations, CAPAs, Change Controls, and trend reports to help ensure issues are appropriately assessed and addressedProviding Quality and compliance expertise during investigations and issue resolution activitiesEnsuring compliance with applicable GMP requirements and marketing authorizationsActing as a Quality spokesperson during Health Authority inspections, internal audits, and customer auditsPerforming check rounds and periodic witnessing of operational processesEstablishing and maintaining effective working relationships with Business and Quality partners and serving as a Quality point of contactSupporting quality oversight of operational activities through review and approval of GMP documentationRepresenting Quality on projects and helping ensure alignment with applicable quality and compliance requirementsEnsuring events with potential impact on patient safety, product quality, and/or product supply are appropriately escalatedThe role contributes to maintaining inspection readiness, supporting compliant operations, and helping ensure quality is embedded in manufacturing activities.Qualifications / RequirementsWe are looking for someone who combines strong quality and GMP knowledge with the ability to collaborate effectively across a manufacturing environment.EducationUniversity degree in Pharmaceutical, Chemical, Biological Sciences, Engineering, or another relevant scientific fieldExperience2–5 years of experience within the pharmaceutical industryKnowledge & SkillsFamiliarity with GMP requirements and pharmaceutical manufacturing environments**Fluent Dutch and English, both spoken and written**Ability to communicate effectively with manufacturing, quality, and cross-functional stakeholders in a bilingual environmentStrong quality-focused approach with attention to detail and accuracyAbility to work independently while maintaining strong connections with key stakeholdersAbility to work effectively within cross-functional teams and maintain constructive working relationshipsAbility to manage competing priorities and perform effectively under time constraintsAbility to make risk-based decisions in a dynamic environmentFamiliarity with risk management principlesStrong analytical and problem-solving skillsContinuous improvement approachKnowledge of pharmaceutical legislation, cGMP regulations, ICH guidelines, policies, and proceduresStrong communication and networking skillsAbility to understand business implications of quality-related decisions and positionsDemonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivityWhat we offerWe offer a collaborative environment where learning, innovation, and professional development are encouraged.In this role, you will have the opportunity to work closely with manufacturing and quality teams, support products that make a meaningful difference for patients, and contribute to the ongoing evolution of quality within pharmaceutical operations.Our commitment to inclusionAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation is powered by bringing together people with different backgrounds, experiences, and perspectives.We are proud to be an equal opportunity employer and welcome applications from qualified candidates of all backgrounds.If you require a reasonable accommodation during the application, interview, or onboarding process, support is available. Please let us know how we can help.#LI-Hybrid#SCQuality
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