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Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Olen, Antwerp, Belgium
Job Description:
At Johnson & Johnson Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at
We are currently looking for a QA release responsible / site QP delegate who has a passion for quality and loves to operate in a very dynamic pharmaceutical production environment. We are looking for a quality expert who likes to work in an international environment and is connecting easily with our different business partners.
Janssen Pharmaceutica Olen is part of the Janssen Pharmaceutica N.V. legal entity. At the J&J Innovative Medicine Supply chain Olen site, pellets are manufactured and released. In this role, you will be located at the Olen site, and you will be reporting to the QA operations manager of Liquids & Creams, CWA/Formulation, Gogu warehouse and Olen. The QA department ensures that all GMP activities of manufacturing, packaging and release are carried out as required by GMP legislation.
What you'll do:
Your role as a QA release responsible/site QP delegate for the Olen site, you ensure that all GMP activities of manufacturing, packaging, labelling, testing, release and distribution of products are carried out as required by GMP legislation.
You are responsible for the daily quality operations within the Olen production area and take up additional responsibilities within the QA liquids & creams 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.
* Attend periodic meetings within the Innovative Medicine Supply Chain and QA liquids & creams, CWA/formulation, gogu warehouse team.
* 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.
* Review and release of batch records.
Qualifications/Requirements:
* You have a university degree with a scientific orientation (pharmaceutical, chemical or biological sciences/engineering) of equivalent by experience.
* 2-5 years' experience in a Pharmaceutical Industry.
* You are certified as a Qualified person.
* 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.
* Undefined.
* 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.
Here's what you can expect:
* Application review: We'll carefully review your CV to see how your skills and experience align with the role.
* Getting to know you: If there's a good match, you'll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
* Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
* Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.
Finally, at the end of the process, we'll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We're excited to learn more about you and wish you the best of luck in the process #LI_Onsite
Required Skills:
Preferred Skills:
Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)