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