GUIDELINES FOR COMPLETING THIS PAGE
• It is a mandatory step to update the Job Description, Work Experience, and
Education sections.
• Click the text/content below the respective section headers to update or edit
the details.
• Do not click the ‘Edit’ button on the right side of the screen, as it is
specifically for system administrators.
• After updating all sections, scroll down, click ‘Save’, and then go back to
the ‘Job Requisition Details’ tab to proceed.
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
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📌 Sr.Officer - Infotech (Tarapur)
🏢 LUPIN
📍 Tarapur