Job Description
Our Client, an IT Services and Consultant company, is looking for a Lab System Validation for their West Point, PA location. Responsibilities:
+ Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
+ Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
+ CSV, GAMP 5 CPFR Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle. Adaptation of CSA and Module Validation is preferred.
+ To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areas
+ Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement.
+ Prepare and execute URS, MVP, VP, R...
+ Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
+ Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
+ CSV, GAMP 5 CPFR Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle. Adaptation of CSA and Module Validation is preferred.
+ To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areas
+ Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement.
+ Prepare and execute URS, MVP, VP, R...