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In this function 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. You have 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.
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
- Working accurately and detecting opportunities for improvement with proper follow up, both on compliance work processes as well as personal development
- 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
- You have a high degree of accuracy, initiative, and independence
- You are flexible and stress-resistant and remains positive when priorities change
- You communicate clearly in English, both verbally and in writing.
- Must be flexible with working hours
An important function within a leading, worldwide operating healthcare company.
Contactpersoon voor deze functie is Jan de Meijer, bereikbaar op telefoonnummer 023 55 78 529 of via e-mail: firstname.lastname@example.org Kenmerk: 9606.