Pepscan is a biotech company with two decades of expert experience in its proprietary CLIPS technology and in providing peptides and peptide services to its customers, who are pharmaceutical and biotech companies as well as universities.
We are serving our customers with finding solutions for their research challenge and for that raising our quality system from ISO 9001:2015 to GMP, to provide the highest quality for the clinical trials of our customers.
For this new strategic step, we are looking for a
QUALITY ASSURANCE LEAD
who will help us to implement and to execute GMP at Pepscan
What do you do as a Quality Assurance Lead?
In this position you are responsible and have a central role in building up and implementing the quality management within the company. You are constantly alert for improvements with regard to quality performance and contribute to improvement projects. You identify, analyze, initiate, advise, implement, follow up and improve!
As a QA Lead you have the following activities:
- Dispositioning of Pepscan products for distribution.
- Training the personnel and building up the company towards a full valid GMP environment.
- Create with the colleagues quality standards and SOP’s, which you will then also monitor.
- Maintain the quality management system (evaluation, advising, designing, implementing and monitoring procedures).
- Carrying out/responsible for internal audits to ensure compliance status and to communicate the progress of solutions to the CEO.
- Gather information in preparation for the root cause analysis in case of customer complaints.
- Trending of customer complaints.
- Maintain communication with the QA department of suppliers.
- Hosting regulatory and customer audits.
What do we ask/job requirements?
- Higher level of education (Master) in Life Sciences or a related field.
- At least 5 years of experience in a GMP environment.
- Experience as quality lead in GMP environment is considered as highly recommended.
- Experience with internal and external audits.
- Knowledge of and practical experience with quality management systems.
- Excellent communication skills at various levels, both Dutch and English.
- Personal characteristics: quality-oriented, pro-active, flexible, accurate, hands-on mentality, stress-resistant, pragmatic, decisive and a team player. Problem-solving skills.
Are you the one we are looking for?
Then don’t hesitate and contact us!
For further information about this position and/or your written application with CV, please send an email to Sylvia Boelens (HR manager) / firstname.lastname@example.org.
More information about Pepscan and an overview of Products & Services that Pepscan offers can be found at our website www.pepscan.com.
Keywords: Vacancy, fulltime, Quality Management, Laboratory, Laboratorium, Laboratoriumonderzoek, Life Sciences, HLO, Master, Lelystad, Flevoland.