Executive
2 weeks ago
Job Description
Ensure Computer System Software Validation and maintaining validated status of all computerized system software as per SOPs in line with cGMP guidelines.
Identifying GAPs in current practices and plan mitigation for each GAP as per agreed time-line.
Participating in various Internal, External and Regulatory Audits and their compliance activities.
Participate in management review to provide status on various on-going projects progress, compliance status and related actionable.
Carry out periodical audits to access the IT systems and give effective solutions if any discrepancy found. Also handle escalations and downtime and ensure change control process.
Coordination with respective OEM/Vendor for any required support for computerized systems.
Ensure required security controls and safe IT working to be established in the environment.
Ensure and facilitate the Backup, Restore & Archival of electronic data of computerized software system.
Ensure timely review and preparation of Backup scheduler for computerized software systems in accordance with the applicable SOPs.
Ensure timely review and preparation of scheduler for data verification/Restoration for computerized software systems in accordance with the applicable SOPs.
Ensure and facilitate the review and implementation on IT security/Data protection policies on computerized systems in accordance with the applicable SOPs.
User Management of computerized systems in accordance with the applicable SOPs.
Work Experience
8-10 years Experience
Education
B.Tech in Computer Science or Electronics
Competencies
Result Orientation
Collaboration
Stakeholder Management
Process Excellence
Innovation & Creativity
Developing Talent
Strategic Agility
Customer Centricity
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