1Csv lead for assigned projects; responsibilities include but not limited to vendor evaluation, creation of project validation plan based on the criticality of the proposed system, in consensus with the vendor, based on their quality systems.
2Perform system risk assessments and review action plans to ensure compliance during and after the system validation.
3Define risk-based strategies for the validation of the systems, which includes but not limited to validation methodologies, testing activities, documentation, and version release protocols.
4Develop and review computer system validation deliverables for accuracy, consistency, clarity, and completeness.
5Reviewing, approving test script/ qualification - perform assigned activities, deliverables, cft meeting co-ordination
6Help, guide and direct the project manager during the system implementation and validation process, ensure compliance with drReddy’s policies and procedures.
7Provide training related to computerized systems validation, quality and compliance to users and appropriate personnel.
8Ensure the compliance of computerized systems to regulatory requirements, including but not limited to 21 cfr part 11 and other applicable regulations.
9Review of change controls with respect to business process, any changes in it systemReview of validation deliverables for it change requests; establishing and implementing corrective and preventive actions and process improvements initiatives for csv projects.
10Facing regulatory, customer, it quality system related inspections for all computerized systems across the company.
11Review of computerized systems post go-live to ensure compliance with the applicable procedures.
12Undertake knowledge management initiatives (gxp awareness, compliance sustenance) like trainer-training related to csv/quality /compliance to cross functional teams.
13Governing department /function kpis, evaluations, analysis of the same, status reporting, alignment & co-ordination with cft.
Skills required: csv
Posted 30+ days ago