Description
Job Role: QA Officers x 2Start Date: December
Duration: 12 months
For our pharmaceutical client in the Netherlands we are currently looking for two QA Officers to support batch record review.
Description:
The QA Officers will work on batch record review and management, review and approval of documents related to defects, both process and lab.
Requirements:
- Bachelor's or Master's Degree in Science or Engineering with at least 5 years of experience in the pharmaceutical industry within Quality Operations.
- Minimum of 3 years experience with exposure to investigations execution in an FDA related environment with technical expertise and strong Quality Systems background.
- Knowledgeable with cGMP's applied to drug product/drug substance and manufacturing is required.
- Technical knowledge in manufacturing processes and analytical testing techniques.
- Effective planning skills.
- Excellent interpersonal and communication (oral and written) skills, in English.
- Technical Writing
- Root Cause Analysis
- Failure Mode & Effect Analysis (FMEA)
- CAPA establishment and Lean Six Sigma.
- Experience with documentation systems and SAP is preferable.
- Dutch fluent.