We are looking for a QA Process Coordinator for a leading global biotechnology organization in Amsterdam. Are you an organized and independent professional with working experience in the pharmaceutical industry and ready for your next challenge? This is what you have been looking for! Read on and apply directly!
As QA Process Coordinator you ensure the swift flow of documentations from and to the QA department. You are responsible for scheduling, review, and release of batch records and test documents, compliant with the overall production plans. You also register, determine, and review production data to make sure it is all completed in a timely manner. You take part in various investigations, for corrective actions and improvements, in quality related issues, while also performing internal audits and drawing up follow-up procedures. As part of the QA team, you represent the QA department in daily operational meetings, and monitor and report quality indicators when needed. You are also responsible for the preparation of annual reports that provide statistical overview of the production release data. As a QA senior, you are also training juniors and new colleagues in the organization as well.
- Ensuring the correct and timely flow of documents to and from QA
- Ensuring batch record reviews and releases are in line with the overall production plans
- Review of batch and test documents, among other relevant production and QC documents in preparation of QA release
- Registration, calculations and assessment of production activity data to make sure it is accurate, complete and in a timely manner
- Participate in investigations related to quality issues and corrective actions
- Perform internal audits
- Train junior and new employees
- Take part in daily operational meetings as the QA delegate
- Bachelor or university-level degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or similar
- Minimum of 5 years experience in the pharmaceutical industry
- In depth knowledge and experience with GMP regulations
- Familiar with MS Office. Knowledge of Veeva and/or SAP is a pre
- Experience with FDA compliance is a pre
- Communicatively strong in both Dutch and English, written and verbal
- Self starting, organized and communicative personality
- Long term position, direct contract with our client
- Salary range: €4600 - €6000, depending on previous experience
- Fulltime position of 40 hours/week, 32 hours is discussable
- Travel costs are reimbursed
- Location: Amsterdam
Vacancy number: 22458
IMPORTANT NOTE: Please do not apply if you do not have a working permit to live and work in the Netherlands. Your application will not be processed.