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GMP and Documentation specialist

Are you experienced in GMP documentation, would you like to be the person that is helping realizing a COVID-19 vaccine?Continue reading, we would like to get in contact!

Job Description
Our client Janssen Vaccines & Prevention B.V. is passionate about the development, production and marketing of vaccines to prevent and combat infectious diseases.he Drug Substance Operations(DSO) department has a GMP manufacturing facility at the Bioscience Park in Leiden
where they proudly produce groundbreaking medicines against diseases that have a global impact, such as vaccines against HIV, RSV, Ebola and of course COVID-19.

The department is working on the manufacturing of cell banks, virus seeds and clinical batches (phase I to III) to supportthe 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. As GMP and Documentation specialist within the Janssen Pilot Facility you are 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.

Responsibilities

  • 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;

  • Working accurately and detecting opportunities for improvement with proper;

  • follow up, both on compliance work processes as well as personal development;

Requirements

  • HBO/BSc with 3 years of proven experience in pharmaceutical/biotechnology;

  • Experience with change controls, non-conformances and CAPA records;

  • Experience with cGMP and EHSS standards is required;

  • Lean green belt certification is preferred;

  • The candidate...

  • has a high degree of accuracy, initiative, and independence;

  • is flexible and stress-resistant and remains positive when priorities change;

  • helps team members by giving advice and sharing feedback;

  • communicates clearly in English, both verbally and in writing;

  • Some flexibility in working hours is required;

  • Must be able to work on multiple simultaneous tasks with limited supervision;

  • Quick learner, motivated self-starter;

  • Excellent customer service, interpersonal, communication and team collaboration skills;

  • Able to follow change management for internal guidelines. Language proficiencies:

  • English and Dutch spoken and written;

Benefits

  • Contract: 1 year through Oxford Global Resources, long term possibilities anticipated but no promises can be made at this stage

  • Salary: €3000,- till €3400,- gross monthly based on level of experience;

  • Hours full-time preferred, 32h discussable;

  • Holidays: 25 (+12);

  • Startdate: Asap;

Vacaturenummer; 15552