Quality Specialist - Interim
Verification and execution of GMP compliance and quality systems
Monitoring and maintenance of the quality systems in manufacturing
About Our Client
Our client is a global Bio pharmaceutical Company focusing on delivering treatment for patients worldwide, through the constant development of current and new therapies. By staying in close collaboration with healthcare institutes and practitioners in the medical field they thrive to serve patients as effective and efficiently possible.
As a Quality Specialist you will be directly involved in three large state-of-the-art projects and be working directly with the Quality, Project management and Operations team to trigger continuous improvement of all processes. Your main focus will be on batch record reviews and solving all the issues that come up at this busy production site.
Main responsibilities include:
- Assisting with quality issues that impact manufacturing
- Verification and execution of GMP compliance and quality systems in the production- and quality areas
- Initiating continuous improvement of routine processes defined with the CMO
- Performing batch record review and master batch review
- Evaluating and supporting investigation of the deviations
- Classifying and handling change controls
- Monitoring and maintenance of the quality systems in manufacturing
- Checking of defined critical process steps during production
- Educating colleagues on GMP guidelines and promote quality awareness
The Successful Applicant
- Bachelor or Master Degree within a relevant field
- Experience working in GMP Pharmaceutical or Biotechnology regulated environments, preferentially in plasma products
- Coordinating experience in the Pharmaceutical industry
- Ability to collaborate cross functional and work at multiple organization levels
- Social competency and integrity: need to communicate with tact and diplomacy
- Personality: Independent, flexible and solution orientated.
What's on Offer
Hourly tariff based on experience and availability.