PawtucketRecruiter Since 2001
the smart solution for Pawtucket jobs

CSV Consultant - Equipment Software

Company: Katalyst Healthcares & Life Sciences
Location: Pawtucket
Posted on: March 20, 2023

Job Description:

Roles & 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.

Keywords: Katalyst Healthcares & Life Sciences, Pawtucket , CSV Consultant - Equipment Software, IT / Software / Systems , Pawtucket, Rhode Island

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Log In or Create An Account

Get the latest Rhode Island jobs by following @recnetRI on Twitter!

Pawtucket RSS job feeds