Quality Assurance Specialist
Our client is one of the largest pharmaceutical organizations world-wide, based in South-Holland. Their portfolio include various therapeutic areas such as oncology, respiratory, cardiovascular or infectious diseases.
As a Quality Assurance Specialist you will be responsible for various activities such as CAPAs, deviation management, change control, batch release... to ensure that the products meet the quality standards.
- Identifies, classifies and reports deviations, as appropriate and typically works on more complex minor and/or major deviations.
- Oversees execution of remediation/CAPA activities required to continue production or move a process to the next mile stone.
- Authors and reviews SOPs and policies. Create and establish process and procedures to ensure compliance and adherence to regulations and cGMP operations.
- Responsible for providing quality oversight to the change management system for change controls.
- Review pre-executed batch records and independent technical review of documentation post-execution of cGMP activities.
- Participate in quality oversight of manufacturing, real-time observations of activities
- Work closely with others to recognize opportunities for improvement and drive change through the use of QMS.
- Participate in internal audits for compliance with SOPs, GMPs, and regulations.
- Bachelor’s degree in biology, or chemistry, microbiology, or equivalent.
- A minimum of 2 to 5 years of Quality Assurance experience in the pharmaceutical industry.
- Demonstrated knowledge of cGMPs in a manufacturing environment.
- Strong independent judgement and decision-making abilities.
- Demonstrated problem detection and problem resolution skills.
- Must possess good verbal and written skills.
For more information please contact Carla Garcia at +31 (0) 20 658 98 01 or firstname.lastname@example.org.