Contract: Q Associate 30402 / The NetherlandsClick here to shortlist this job 1-CLICK Apply With Employer or Register Now
|Location:||Breda, North Brabant, The Netherlands|
The client are looking for a QA Associate in the Breda area on an initial 12 month contract with the potential to extend.
Please note that this is a 3 shift cycle role
Main Responsibilities of the role
- Provide daily guidance and support to Production staff in regards to compliance with Standard Operating Procedures and Work Instructions.
- Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.
- Review and approve batch production record data entries before production activities take place
- Perform finished product checks during (commercial) production runs
- Compile and review batch records for lots assembled, packaged and labelled and contract manufacturers in preparation for disposition by QP.
- Review of operational SOP's and Work Instructions as needed
- Review and approve deviation records
- Initiate and own QA deviations as needed.
- Perform GMP compliance checks in production
- Assist in development and delivery of GMP training activities for QA and production staff
- Participate in QA production related projects as needed
- Assist in various investigations as needed
- Assist in projects and improvement efforts as needed
- Responsible for preparation of weekly/monthly metrics
- Own and maintain departmental performance boards
Desired Experience and Background of the successful candidate
- 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 with experience in batch record review and investigations.
- 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.
- Manufacturing and/or Quality analytical processes and operations.