QA Documentation Officer

Locatie: Leiden, Zuid-Holland, Nederland
Salaris: competitive
Sectoren: Quality Assurance
Soort functie: Freelance
Solliciteren
For one of my clients in the area of Leiden I'm searching a QA Officer. You will be working within the pharmaceutical industry. Are you available on short notice or are you interested in a QA Officer role? Please continue reading!
QA Officer
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. 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.
As the QA Officer 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.
Daily job description
* 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
Competencies & skills
* 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
* Communication skills in Dutch & English are required.
Send your application now!
Are you enthusiastic about this vacancy, do you want to learn more about this or do you know someone who would be perfect for this position? Please do not wait any longer and contact Celine Stevens via 020 522 1279 or c.stevens[at]realstaffing.com.
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