CSV Consultant - Equipment Software
Company: Katalyst Healthcares & Life Sciences
Posted on: March 20, 2023
Roles & Responsibilities:
- Draft and implement Quality System documentation designed to
establish good validation practices within the
- Author URS, FRS, Risk Assessments, Configuration specification,
design specification and CSV test protocols and execute them in
compliance with GDP guidelines and internal quality
- Author and develop SOP and VMP for computer system validation
for manufacturing equipment.
- Design validation approaches, supported by appropriate
statistical analyses, perform and/or coordinate all validation
activities, analyze and assemble results, and draft validation
- Provide input on user and/or functional requirements of current
and future processing equipment, and draft appropriate
documentation. Additionally, interface with Contract Manufacturers
to ensure all relevant user and functional requirements are
- Provide support to non-engineering Staff, including those from
R&D and Manufacturing, to ensure successful technology transfer
and continuous improvement.
- Execute assigned duties on time and pro-actively telegraph
delays and other issues to validation manager and other relevant
- Comply with all regulatory, corporate, and Quality System
- Experience in the areas of Design Documentation (URS, FRS, CS,
DS, and other engineering specifications) and Validation (OQ, CSV,
- Understanding of c.G.x.P principles and familiarization with
ISO 13485, ISO 14971, and 21C.F.R.820
- Working knowledge GAMP 4 and GAMP 5 categorization and their
respective deliverables for Computer Systems Validation
Keywords: Katalyst Healthcares & Life Sciences, Pawtucket , CSV Consultant - Equipment Software, IT / Software / Systems , Pawtucket, Rhode Island
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