CLS Services

Gepubliceerd: 25 days ago

GMP and Documentation specialist COVID

Leiden
Gepubliceerd: 25 days ago
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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, Janssen Vaccines & Prevention, we are searching for a GMP and Documentation specialist COVID .

Company profile
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.

Department
The DSO department 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. Their passion is to deliver high-quality results to their 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, master batch documentation, training and inspection readiness.

Job description
Do you want to help to realise the upcoming COVID-19 vaccine manufacturing campaign? We are looking for a GMP and Documentation specialist to strengthen the Operations Support Team within DSO.
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.
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;
  • Co-ordinating 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.


Who we're looking for
The ideal candidate has a detailed understanding of cGMP and GMP documentation systems, such as Veeva truVault. You are an expert in handling non-conformances and follow-up. With process excellence/lean experience you are able to identify and lead compliance improvement projects.
We are looking for candidate with strong knowledge of FDA regulations and GMP.
  • 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;
  • Experience with documentation systems required (Truvault preferred);
  • Lean green belt certification is preferred.


Additional vacancy information
Reference: A2000052
Contract: Temporary contract with CLS Services
Education: HBO/BSc.
WO/MSc.
Terms: Project for 1 year. In principle this is temporary additional resource requirement due to excess work, not anticipating extension at present. Full time preferred, 32 hours discussable. This would normally be an on-site role with only a 1 day per week work from home option.

Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555

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