Vacature Officer QA

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Officer QA

• Job Title Officer QA
• Function Quality
• Sub Function Quality Assurance
• Location Leiden, South Holland, Netherlands
• Date Posted Oct 24 2023
• Requisition Number 23W

Description

The Company: Janssen Biologics B.V. is a multinational pharmaceutical company that is a leader in the field of biomedicines. Through the dynamic science of biotechnology, we are passionate about the development, production, testing of antibodies and advanced therapeutics to prevent and combat diseases in the area of immunology, oncology and infectious diseases. Janssen Biologics is part of the Johnson & Johnson family of companies.

The Department: As Quality Assurance we take a stand to consistently ensure the delivery of safe, effective and high-quality products for the patients in need. The QA department has a commercial and an NPD (New Product Development) & Launch branch. This position will be placed within the NPD & Launch group. QA NPD & Launch provides end-to-end Quality support (i.e. non-conformance management, CAPA, change control, validation and batch disposition) for our new biological products and advanced therapies. These products will be used in Clinical Studies and beyond to prove their safety and efficacy prior to their commercialization. This is a quick evolving and dynamic environment.

The Position: At QA NPD & Launch, we are currently looking for a QA Officer, with strong knowledge of both cGMP guidelines and Quality Management systems, to join our team. As an enthusiastic QA Officer NPD & Launch with a strong sense of urgency and a passionate commitment to getting things done, you will contribute to the Quality support for all New Products quality related topics within the Leiden manufacturing site (i.e. development departments, production facilities and quality control labs). In addition to the base business activities for our products, the company also has a large project portfolio to improve on our processes, implement new technologies and increase our capacity to be able to deliver future demands.

Activities and responsiblities:

The QA Officer acts as a quality expert and applies our Quality Systems to create, review and approve GMP documentation. In this position you report to Manager QA NPD & Launch and will work together with QA officers and QA Associates.
• Review and approve analytical method transfer protocols and reports
• Perform batch record review (paper and electronic)
• Release Raw Materials (supplies)
• Provide review and approval of document changes and change controls
• Review and approve validation assessments, protocols and reports
• Prepare release packages
• Track and monitor progress to anticipate, flag and prevent any delays
• Act as member for local or global capacity/quality projects
• Optimize current Quality Processes

Qualifications

Job requirements:
• BSc/HBO (or equivalent) in Biochemistry, Biology, Pharmaceutical degree or relevant education.
• Ability to drive collaboration in a fast-paced environment
• Preferable some years of QA experience in the biotechnological/pharmaceutical or related industry
• Experience with documentation systems like Trackwise, True Vault is preferable
• Experience in Change control and all documenting related activities
• Problem solving and analytical capability, eye for details
• Good communicative and advisory skills in English both in word and writing. Dutch is a pre
• Able to work independently as well as in a team

We invite you to join our Global Talent Hub, where we keep in touch with people around the world who share our passions for bold innovations and are inspired by our mission of changing the trajectory of human health.

：1-800-458-1653

Contact Information: 1-800-458-1653

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Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

Functie:	qa officer
Startdatum:	23-10-2023
Ervaring:	Ervaren
Educatielevel:	HBO
Contracttype:	Vast
Salaris:	onbekend – onbekend
Uren per week:	1 – 40

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