Computer system Validation tester
Apply NowCompany: Clifyx
Location: Somerset, NJ 08873
Description:
Description:
8+ years of experience in CSV Implementation
Computer System Validation, Life cycle, Process Validation, Risk Assessment, FDA standards, Test Planning, Corrective Action Plan
Experience in CSV for Lab systems especially LabVantage version 8, Serialization, trackwise systems
CSV/21CFRPart11/GxP/
Ensure compliance to industry standards like GAMP5, FDA 21 CFR Part 11 on electronic records, electronic signatures etc.
Define Risk based strategies for validation of computerized systems and author/review end-to-end Computerized Systems Validation documentation in accordance with Computerized Systems Validation Master Plan
Perform system risk assessments, systems gap analysis, review and approve action plans to ensure compliance during and after the system validation
Draft SOPs, writing scripts for IQ, OQ, PQ and handling CSV
Help, guide and direct the project manager during the system implementation and validation process, and ensure compliance with corporate policies and procedures.
Provide training related to computerized systems validation, quality and compliance to users and appropriate personnel
Experience in Internal Audit, External Audit. Face regulatory, customer, IT Quality System related inspections for all computerized systems
Responsible for review & verification of Corrective Action Plan for audits
Perform periodic review/monitoring of computer systems implemented
Proven experience in developing Master Validation Plan, validation scripts, Validation reports, all documentations required during CSV Implementation Process
Key Skills: Computer System Validation for Lab systems
8+ years of experience in CSV Implementation
Computer System Validation, Life cycle, Process Validation, Risk Assessment, FDA standards, Test Planning, Corrective Action Plan
Experience in CSV for Lab systems especially LabVantage version 8, Serialization, trackwise systems
CSV/21CFRPart11/GxP/
Ensure compliance to industry standards like GAMP5, FDA 21 CFR Part 11 on electronic records, electronic signatures etc.
Define Risk based strategies for validation of computerized systems and author/review end-to-end Computerized Systems Validation documentation in accordance with Computerized Systems Validation Master Plan
Perform system risk assessments, systems gap analysis, review and approve action plans to ensure compliance during and after the system validation
Draft SOPs, writing scripts for IQ, OQ, PQ and handling CSV
Help, guide and direct the project manager during the system implementation and validation process, and ensure compliance with corporate policies and procedures.
Provide training related to computerized systems validation, quality and compliance to users and appropriate personnel
Experience in Internal Audit, External Audit. Face regulatory, customer, IT Quality System related inspections for all computerized systems
Responsible for review & verification of Corrective Action Plan for audits
Perform periodic review/monitoring of computer systems implemented
Proven experience in developing Master Validation Plan, validation scripts, Validation reports, all documentations required during CSV Implementation Process
Key Skills: Computer System Validation for Lab systems