Our client, who is an international pharmaceutical, is looking for a QA Specialist/GMP Documentation Control in Leiden.
All applicants MUST have full legal authorization to work in the EU region independently and be fluent in both spoken and written English language.
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. Our client is passionate 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,
masterbatch documentation, training and inspection readiness.
To strengthen the Operations Support Team within DSO, they are looking for a QA Specialist/GMP Documentation Control to help them realize the upcoming COVID-19 vaccine
About the position:
The QA Specialist/GMP Documentation Control within the 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.
·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
· 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
· 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.
What do we offer
- Contract via Kelly for 12 months (possible extension)
- Start date: ASAP
- Salary indication depending on experience
Please do contact Marcella Henryati, Recruitment Consultant
T: 023-7111189 / 06-58811958
When interested please apply with your English resume on our website: www.kellyservices.nl
It's more than a job. It's passion. Our vision is to provide the world's best workforce solutions. We are authentic, the industry founder. We believe in relationships, not transactions. We value teamwork, realizing that we are stronger together than as individuals. We take seriously the promises we make. We are passionate, dedicated and driven to excel. With us it has never been about being the biggest. It has always been about being the best and doing the right thing.
At our core, we are a community. Each day we welcome into our community the varied talents of all people who embrace our culture of service, teamwork and integrity. We offer the opportunity to work with the best companies in the world, and to make a difference in the communities in which we live and work.
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Regarding this role, Kelly Services acts as the official temporary employment agency. When you decide to apply to this role your personal information will be processed in accordance with Kelly's Privacy Statement
In keeping with the AWGB (Algemene Wet Gelijke Behandeling) Kelly Services welcomes applications from any and all eligible candidates regardless of ethnicity, gender, disability, religion, sexual orientation or age.