One of our leading Biotech clients in Breda has a job opening for a QA Officer. We are looking for someone who has experience with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.
Position Specific Tasks
•Perform review and approval of Master Data related activities (such as critical value verification and Bill of Materials).
•Perform approval of artwork for medicinal products.
•Act as author for operational SOP’s and Work Instructions
•QA Review of operational SOP’s and Work Instructions
•Participate in QA related projects as needed
•Assist in various investigations as needed
•Responsible for preparation of weekly/monthly metrics
•Own and maintain departmental performance boards
•Support ABR data gathering in support of the Annual Product Review Process
•To perform QA review and Approval for SAP Master Data and artwork
•To ensure QA systems are maintained, improved and performance is appropriately monitored
•To establish effective working relationships with the Global Artwork Center, Master Data, SCPM, Site SME’s and RA department, as well as QA Management
Understanding and application of principles, concepts, theories and standards of technical/scientific field
Specialized knowledge within own specialty area
-Deepens technical knowledge through exposure and continuous learning
Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
Applies research, information gathering, analytical and interpretation skills
to problems of diverse scope
-Ensures compliance within regulatory environment
-Develops solutions to technical problems of moderate complexity
-Screens, categorizes, evaluates, reconciles, reports and resolves data integrity issues
-Interprets generally defined practices and methods
•MBO or Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience.
•Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry
•Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.
•Fluent in English language.
- 12 months (high chance of extension)
If you are interested in the above description, apply with your CV
PS: Did you also know that we offer an attractive referral scheme?
For more information please contact Selin Ozbeden on +31 (0)20 20 44 502