QA Specialist
QA, New Product Introduction, Qualification, GMP
Vacature
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.For our client Johnson & Johnson Innovative Medicine we are searching for a QA Specialist.
Keywords
- Quality Assurance
- New Product Introduction
- Qualification of equipment
- Qualification of processes
- GMP
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As an experienced QA Specialist, you will serve as a quality expert, providing essential quality oversight for the AT products and processes. In this role, you will play a key part in ensuring that the manufacturing operations consistently meet the highest standards of quality and GMP compliance. You will support a variety of business activities that require strong quality assurance expertise and collaborate closely with both local and global teams—including Operations, Warehouse, QC, GET, MSAT.
In this role:
- You will provide critical quality oversight for our Advanced Therapies manufacturing operations;
- You will support new product introductions and equipment qualifications, ensuring all activities meet the highest GMP standards;
- You will lead and review quality investigations, assess non-conformances, oversee CAPA implementation, and support decisions on product disposition;
- You will contribute to risk assessments, internal audits, and aseptic processing oversight, helping safeguard product quality and patient safety;
- You will provide GMP training, review and approve documentation and change controls, and drive continuous improvement within QA processes;
- You will also serve as a subject matter expert on local and global projects and participate in a rotating on-call schedule to provide after-hours quality support when needed.
Profiel
For this position we are looking for candidates with a scientific degree and with 4–6 years of GMP experience, including at least 2–4 years in a QA role within the pharmaceutical industry.You have:
- Strong expertise in quality systems and GMP compliance, with knowledge of aseptic processing and sterile manufacturing considered as a strong advantage;
- Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended;
- Excellent analytical, problem-solving, communication, and stakeholder management skills, with the ability to make decisions;
- Highly organized and proactive, able to manage multiple tasks independently, with professional proficiency in English (Dutch preferred but not required).
Are you the experienced and motivated QA specialist we are looking for?
Arbeidsvoorwaarden
Contract for one year, maternity leave cover.Salary: max. 70000
Days of leave: 36
See here our other employment terms for this vacancy
Bedrijfsprofiel
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.
They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.
