Quality Assurance Specialist

Locatie: Leiden, Zuid-Holland, Nederland
Salaris: competitive
Sectoren: Life Sciences
Soort functie: Freelance
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Would you like to be the person that is helping us realizing a COVID-19 vaccine? Continue reading, we would like to get in contact! Janssen Vaccines & Prevention B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson and is passionate about the development, production and marketing of vaccines to prevent and combat infectious diseases. The Drug Substance Operations (DSO) department has a GMP manufacturing facility at the Bioscience Park in Leiden where we proudly produce groundbreaking medicines against diseases that have a global impact, such as vaccines against HIV, RSV and Ebola. This is also the place where we will be producing the COVID-19 vaccine material. To strengthen the Operations Support Team within DSO we are looking for a GMP and Documentation specialist, to help us realize the upcoming COVID-19 vaccine manufacturing campaign.

Department

The department DSO is an international team of about 40 people working on the manufacturing of cell banks, virus seeds and clinical batches (phase I to III) to support the development of new vaccine candidates. Manufacturing activities are performed under strict cGMP regulations and the process is established together with development departments, engineering & maintenance, QC, QA and warehouse. Our passion is to deliver high-quality results to our customers and to seek for opportunities for improvement: never a dull moment!

Within the department four teams operate, each with specific responsibilities:
Preparations, Cell culture, Downstream processing and the Operations Support Team. The teams are responsible for their cGMP status by maintaining the documentation system, reporting quality issues and performing the resulting corrective actions, masterbatch documentation, training and inspection readiness.

Job description
The GMP and Documentation specialist within the Janssen Pilot Facility is the first point of contact within the production teams for questions related to cGMP (training, inspections, audits and documentation). In different team settings, you will work on the maintenance and improvement of the available cGMP systems.

The candidate has a detailed understanding of cGMP and GMP documentation systems, such as Veeva truVault. She/he is an expert in handling non-conformances and follow- up. With process excellence/lean experience you are able to identify and lead compliance improvement projects.

As GMP and Documentation specialist, you will be responsible for:

· First departmental contact for questions about cGMP systems
· Initiating and handling of compliance records (Change Control, nonconformances and CAPA records) including root cause analysis
· Supporting/leading in keeping process documentation up-to-date
· Coordinating training system within the department
· System ownership of general production processes like gowning, routing and flow, segregation
· Leading role in the inspection readiness of the department, execution of inspections and follow up

For more information and to apply, send me an email with your most recent CV + Cover Letter to; j.vanbaalen(@)progressive-nl.com

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