- Overseeing and giving quality direction for key areas such as: Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems.
- The QA Specialist will ensure that strong procedures and programs are in place that adhere to regulations.
- Approving and reviewing of Quality Process Development/ validation documentation such as: DS/ QRAES documents, validation Plans, Protocols, IQ, OQ, PQ.
- During new product introductions/ Technology transfer/ Process validation, you will act as point of contact and make decisions.
- The QA Specialist will give input with the Change Control Review Board and oversee QA in regards to change control and Deviation/CAPA records.
- Authoring, reviewing and approving SOPs.
- The QA Specialist will have a BSc. in a scientific/ Engineering discipline with 5 years relevant experience as an SME in Quality (pharmaceutical or biotechnology industry).
- Good understanding of Validation and NPI
- Experienced with change control, non-conformance, CAPA's, and validation practices.
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