CheckMark Labrecruitment

Gepubliceerd: 25 days ago

GMP Documentation Specialist COVID-19

Leiden
Gepubliceerd: 25 days ago
Solliciteer nu
Waar ga je aan de slag - Where will you work

Our client is one of the biggest companies in health care, specialized in the development, production, and marketing of vaccines to prevent and combat infectious diseases. The Drug Substance Operations (DSO) department has a GMP manufacturing facility. Here medicines against diseases that have a global impact, such as vaccines against HIV, RSV, and Ebola, are produced. This is also the place where the COVID-19 vaccine material will be produced.

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

Wat ga je doen - What will your job be

As GMP Documentation specialist COVID-19 you will be the first point of contact within production teams for questions related to cGMP (training, inspections, audits and documentation) to support the development of the upcoming COVID-19 vaccine.

As GMP Documentation specialist COVID-19 you will be the first point of contact within the production teams for questions related to cGMP (training, inspections, audits and documentation). The teams are responsible for their cGMP status by maintaining the documentation system, reporting quality issues and performing the resulting corrective actions and masterbatch documentation. It is you responsibility to maintain and improve the available cGMP systems. Therefore you:

  • Be the first departemental contact for questions about cGMP systems
  • Initiate and handle compliance records (Change Control, nonconformances and CAPA records) including root cause analysis
  • Support in keeping process documentation up-to-date
  • Coordinate training systems within the department
  • Have system ownership of general production processes like gowning, routing and flow, segregation
  • Have a leading role in the inspection readiness of the department, execution of inspections and follow up
  • Work accurately and detect opportunities for improvement with proper follow up, both on compliance work processes as well as personal development

Wat vragen wij - What are we looking for

For the position of GMP Documentation Specialist COVID-19 we are looking for a HBO candidate with multiple years of proven experience in the pharmaceutical industry. You have:

  • Experience with change controls, non-conformances and CAPA records
  • Experience with cGMP and EHSS standards is required
  • Detailed understanding of cGMP and GMP documentation systems, such as Veeva truVault
  • Furthermore, 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

Wat hebben we te bieden - What do we offer
  • A contract for 12 months at CheckMark
  • Salary range starts at €3087 gross per month based on 40 hours/week
  • Full-time position, where 32 hours a week is negotiable
  • Dayshift

Wil je meer weten - More information

Neem voor meer informatie contact op met Jurjen Wilschut: 0182 590 212
Vacaturenummer: 6614

Solliciteer nu