Quality Specialists Operations

Quality Specialists Operations

Leiden, 6 months, 40h, Hybrid way of work 

Johnson & Johnson Worksense is responsible for finding, engaging, and contracting talent for the Johnson & Johnson contingent workforce.

We are currently recruiting a Quality Specialists Operations to join our contingent workforce on a growing team in Janssen Biologics in Leiden for an initial 6-month contract. 

Janssen Biologics B.V. is a multinational pharmaceutical company that has been for more than 25 years a leader in the field of biomedicine. Through the dynamic science of biotechnology, we continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders (I.M.I.D.s), such as rheumatoid arthritis and psoriasis. Janssen Biologics in Leiden is currently manufacturing COVID 19 vaccine (Drug Substance) vaccine. Janssen Biologics is part of the Johnson & Johnson family of companies. The department of Operations is responsible for the execution of the process and making of the product. This role sees that quality systems are applied as per GMP standards within Janssen Biologics. 

In this role, you will be the primary point of contact for Operations regarding cGMP-related activities such as the deviation and change control process, audits, evaluations, trend reports, cGMP compliance, and training within Operations with that responsibility for the improvement of the overall quality status. You will work and have the drive for deviation and change control process and represents Operations.

You must build a strong network within the company; be involved in GMP-related projects and adjustments. The activities are very dynamic and varied. The candidate loves challenges, doesn’t avoid problems, and enjoys working in various teams. You need a high-level overview and have a GMP-mind to support all ongoing investigations.

You as a Quality Specialists Operations will be responsible for:

• Ensure that in a timely manner clear and quality input is given to cGMP and/or quality-related issues encountered during (non)routine Operations. Lead all aspects of quality record investigations and ensure that all CAPAs are implemented and effective within agreed timelines.
• Raise serious quality, compliance, and /or GMP incidents to Operations Management.
• Setup and coordinate Site critical issue meetings.
• Identify improvements within Operations in Quality records and implement these in the process and/or documentation.
• You will own the deviations within Operations. This implies
  • establishing and maintaining a structured deviation process
  • representing Operations in improvement projects
• You are responsible for drawing up and finalizing change controls

You as a Quality Specialists Operations have:

• BSc/MSc in a science-related subject 
• 4-6 years of proven work experience in a business-related area with a proven GMP background
• Experience in working with TrackWise
• Ability to drive collaboration in a fast-paced & complex  environment
• Excellent verbal and written communication skills in English, including the ability to effectively communicate with internal and external customers
• Problem-solving and analytical capability, eye for detail

If you meet our requirements and are interested in hearing more about our Quality Specialists Operations role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!

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