Executive Production Documentation
Job Description:
Documentation & Compliance
Prepare, review, control BMRs, SOPs, logbooks, and formats.
Ensure cGMP & ALCOA+ compliance in documentation.
Manage DocuSign workflows, approvals, revisions, and closures.
Maintain archives for audits/inspections.
Production Support
Record and verify production data in SAP/digital systems.
Coordinate with QA/QC/Engineering/Stores for timely closures.
Review PISCADA reports with batch documentation.
Support OQ/PQ documentation for equipment/utilities.
QMS & Regulatory
Manage QMS activities (change controls, deviations, CAPA, incidents).
Ensure audit readiness and record availability.
Participate in audits and provide documentation.
Training & Improvement
Train staff on documentation & cGMP practices.
Implement learnings from GMP/safety programs.
Support OE initiatives, AET projects & CSR activities.
•Strong knowledge of cGMP, GDP (Good Documentation Practices), and regulatory guidelines.
•Proficiency in SAP and electronic documentation systems ( Knowledge in SAP HANA will be added advantage )
•Detail-oriented with strong data integrity and compliance mindset.
•Good communication and coordination skills for cross-functional interactions.
•Ability to handle audits and regulatory inspections confidently.
Qualification : B.Tech / M.Sc
Contract period 1 year, On Third Party Payroll (Talisman HR)
Interested can share updated cv on search@talismanstaffing.com or What's app : 9136435341
Key Skills :
Company Profile
MNC ---ceutical industry, the discovery, development, and manufacture of drugs and medications
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