Job Description
Our client is looking for a CSV Consultant to come on-site. This is computer systems validation for Equipment Software. The client does not need a CSV Consultant with Enterprise Software experience. They need someone with Equipment Software experience. This is very important. Some of the equipment is complex Robotic equipment, so any robotic software experience is a plus. The consultant will be writing and executing Software Validation Protocols, Doing Risk Assessments, and working with the URS. GAMP 4 & GAMP 5 experience is needed for this role. Also looking for a 21 CFR Part 11 experience. 5 years plus of Computer Systems Validation/Software Validation experience. Any CSV experience in the life sciences industry would suffice for this role.
Responsibilities:
- Draft and implement Quality System documentation designed to establish good validation practices within the organization.
- Author URS, FRS, Risk Assessments, Configuration specification, design specification and CSV test protocols and execute them in compliance with GDP guidelines and internal quality standards.
- 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 reports.
- 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 met.
- 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 stakeholders.
- Comply with all regulatory, corporate, and Quality System policies
- Experience in the areas of Design Documentation (URS, FRS, CS, DS, and other engineering specifications) and Validation (OQ, CSV, etc.),
- 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 lifecycle.
Skills
Equipment Validation, GAMP 3,4, 5, Risk Management
Pawtucket RI: CSV – Equipment Software – GAMP5 (232607)
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