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Senior Process Engineer Melbourne
PSC Biotech
Melbourne, AUS
Contract
Senior
Onsite
Discovered 2 weeks ago
Kneat
Free
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Key Skills for This Role
Kneat
Full Job Posting
Requirements
- Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
- Proficient in developing SOPs, final reports and validation & quality policies.
- Strong experience developing and executing CQV protocols.
- Strong experience creating and maintaining CQV policies and processes.
- Has good understanding and complies to cGMPs and CFR21 Part 11 guidelines.
- Exposure to digital and paper-based validation systems, including platforms such as Kneat .
- Background in Pre-filled syringe (PFS) technology, Vial Filling, Sterile Filtration, Bulk Product, New Product Initiative (NPI) manufacturing, Plasma Manufacturing
About PSC Biotech
BiotechnologyFounded 1996
Provides regulatory, quality, and engineering consulting services for life sciences.
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