Computer System Validation Consultant/AM

Role & responsibilities

• Support on IT quality systems framework design and implementation
• Managing the reviews and assessments for IT quality
• Assist in Computer System Validation (CSV) compliance of GxP processes for

pharmaceutical companies or experience on quality compliance services for global consumer

health care, medical devices, and pharmaceutical companies

• GxP Business process review
• Development of integrated GxP and IT compliance
• Standard operating procedures and guidelines
• GxP and IT compliance assessment
• Define the Validation strategy of IT Software and Systems
• Actively participate in the Validation Life Cycle of regulated IT projects or platforms by

planning validation deliverables, working on validation documentation, participating in

authoring deliverables, functional requirements definition, traceability matrix, validation

protocol development,

• Validation testing and deviation management; and working closely with cross-functional

project teams.

• Ensure 21 CFR Part 11 compliance for Computerized system
• Provide User training on CSV and increase awareness about compliance
• Responsible for reducing Gaps identified in various GAP/Risk Assessments existing and new

computerized systems and providing a remedial action plan for compliance.

• Carrying out an Audit of IT systems to ensure regulatory compliance
• Manage the specified business/systems requirements, working closely with the designated

Project Manager to facilitate the progress of the project Coach/mentor staff and provide

technical leadership, as needed

Preferred candidate profile

• IT Quality, Regulatory, Compliance (IT-QRC)
• Quality guidelines mentioned by FDA, MHRA, and other regulatory bodies
• GxP practices and GAMP5 guidelines.
• Computer System Validation of various COTS products like COGNOS, IMPACT, BAELN and

other related applications used in pharmaceutical industries

• Experience in activities like Business Analysis, Risk Identification, FRS creation and other

validation testing deliverables.

• Good understanding & practical experience of 21CFR Part 11 and other FDA GxP regulations.

Qualification

• • B.E./B.Tech./MCA/MBA/M.Sc/B.Pharm/M.Pharm or similar
• • Experience range 2 years to 8 years