Lead - Quality IT (CSV)

2 weeks ago


Vadodara, Gujarat, India SUN PHARMA Full time

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.
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