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Job Description
A) Operations, control and Monitoring and cGMP: Compliance: - 1. Ensure compliance with all cGMP, GxP, or any other regulatory requirements, including EH&S; requirements. 2. Ensuring compliance and Implementation of all SOPs including Corporate, Site Specific. 3. Ensure Computer System Software Validation and Maintain the Validated status of all Computerized System Software as per SOPs in line with cGMP guidelines. 4. Identifying GAPs in current practice and plan mitigation for each GAP as per the agreed timeline. 5. Prepare a comprehensive support matrix to support day-to-day functions. 6.



Maintain control to ensure that all team members are trained on the relevant SOPs and support continuous learning/ capability building. 7. Encourage a culture of quality compliance and open communication that supports all employees to raise quality concerns or suggest improvements. 8. User ID creation as site IT administrator 9. Preparation and Review of Incident Investigation report, Scheduler, Preventive Maintenance, Implementation of Security Controls. 10. Periodical Audit Trail Review as per SOP and participating in various internal/External audits. Reports and Management Review 1. Prepare and participate in management review to provide status on various ongoing projects progress, compliance status and related actionable.2. Carry out a periodical audit to access the IT system and give effective solutions if any discrepancy is found. Also, handle escalations and downtime and ensure the change control proce

📌 Sr.Officer - Infotech (Tarapur)
🏢 LUPIN
📍 Tarapur