Title:  Lead - Quality IT (CSV)

Job Responsibilities:

• Perform review of Computerized System Validation of IT systems of Manufacturing Sites
• Support various phases of Computer System including Planning, Implementation, Maintenance and retirement activities by ensuring compliance with internal / external regulatory requirements
• Perform GxP computerized systems assessment referring requirement of 21 CFR part 11, EU Annex 11, applicable regulatory standards, adequate security and controls

• Support sites for audit readiness with respect to CS validation, electronic data management and to comply an internal/ external audit observation
• Ensure key documentation of computerized systems consistently meets required quality standards throughout its lifecycle
• Perform periodic validation status review of computerized systems with the support of relevant stakeholders

• Provide support/guidance to remediate legacy/non-compliant computerized systems, to ensure compliance with applicable regulatory standards
• Perform assessment of vendors whenever new Vendor is introduced in organization to assure vendor’s Quality Systems are effective and meet standards
• Timely communicate/discuss identified gaps to responsible team. Coordinate with relevant team for compliance/closure of the identified gaps
• Support projects/initiatives for simplification, harmonization and productivity enhancement 
• Mentor and provide support in the education and training of personnel in relevant areas of compliance and validation for GxP IT systems.
• Perform other duties as assigned by Functional Head time to time.