My client the world leader in developing and commercializing innovative biopharmaceuticals is looking for a QA Associate to join their ever-growing team.
You will be supporting site quality systems, manufacturing operations, site start-up, and inspection readiness.
- Prepare the site for GMP operations.
- Review and approve electronic and paper production batch records.
- Daily presence and support of the manufacturing floor.
- Release of raw material for production.
- Act as a support for the Technology Transfer of new product (raw materials and supplier qualification)
- Review and approve SOPs and master batch records and Change Control
- Review and approve Trackwise deviation and investigation
- Assist with regulatory inspections.
- Level 8 in Science or in a technical discipline (physical, engineering chemical, or biological sciences) is required.
- 3+ years relevant experience in a cGMP regulated manufacturing environment.
- Experience in supporting manufacturing operations. Batch record review is highly desirable
- Excellent communication skills with the ability to support cross-functionally.
- Ability to comprehend technical information.
For a confidential discussion on this or any other current job opportunity please contact Meggan on 021 235 9144 / firstname.lastname@example.org
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