Job Descriptions and requirements:
a.Validation and Qualification:
· Ensuring the Computer System Validation is in alignment with the Validation Master Plan for Computer Systems (CSV-MP). Prepare the CSV document to validate its compliance to design, installation, operation and performance so as to meet the predefined quality attributes of the products.
· Ensure timely completion of all validation related activities including computer system, equipment, utilities and facility with compliance.
· Execute and review computer system validation protocols and reports.
· Review of installation, operational and performance qualification protocols and reports of equipment/utilities/facility.
· Review of Incidents and deviations related to computer system validation and IT systems.
· Participate in CFT meeting related to IT systems and ensure the completion of pending actions.
· Review of IT logbooks to ensure compliance with SOP.
· Periodic Review of IT application and system implemented and compilation of reports.
b.Documentation Compliance:
· Involve in the execution & supervision of validation as per the approved protocol, shall co-ordinate with the cross functional team and external service provider in order to meet qualification & validation excellence so as to keep equipment, system and process in validated status.
c.Audit Management:
· Ensure the completion of CAPA with respect to validation and qualifications.
· Review the site internal audit compliance report and submit it to corporate Internal audit team, for further actions.
· Support the assessment of vendor documents for CSV deliverables.
· Coordinate with external service providers for execution of CSV activities if applicable
· Conduct vendor audit related to IT software applications
· Participate and Support internal surveillance audit and external audits
d.QMS:
· Support QMS documentation system and audit in order to ensure compliance to QMS/Customer/Regulatory requirements.
· Responsible for tracking of QMS events and review and closure of CAPA, change control, effectiveness check, Incidents, and deviations for IT systems.
e.Quality Risk Management:
· To review the process & equipment in co-ordination with cross functional team in order to identify the risk, review the adequacy of current control measures of each process steps and the system as a whole, as per organizations requirements and regulatory guidelines, so as to initiate mitigation strategy.
f.GAP Analysis:
· Review validation document, SOP/Guideline, system, process in coordination with cross functional team. Based on any changed Regulatory requirement or feedback from shop-floor or any comments from previous audit, incorporate changes, inform superior, seek appropriate approval and authorization in order to identify GAPs so as to initiate desired actions with CFT for bridging of GAPs.
