Key ResponsibilitiesDocumentation Management
- Prepare, compile, review, and maintain project documentation.
- Coordinate preparation of FAT, SAT, DQ, IQ, OQ, PQ protocols and reports.
- Prepare SOPs, Manuals, Datasheets, Technical Files, and Validation Documents.
- Maintain document revision history and document control records.
- Ensure all documentation complies with GMP, cGMP, FDA, and GAMP requirements.
Project Coordination
- Coordinate with Design, Automation, Production, QA, and Project departments for document collection and updates.
- Track document submission schedules and customer approvals.
- Ensure timely issuance and closure of documentation deliverables.
- Support project execution through proper documentation management.
Customer Documentation
- Prepare and submit final documentation dossiers to customers.
- Address customer comments and document revisions.
- Maintain records of approved and submitted documents.
- Support customer audits and inspections related to documentation.
Record Keeping & Compliance
- Manage electronic and hard-copy documentation systems.
- Ensure document traceability and compliance with company procedures.
- Maintain project-wise document registers and trackers.
- Support internal and external audits.
Required Qualification
- Bachelor's Degree / Diploma in Mechanical Engineering, Electrical Engineering, Instrumentation, Pharmacy, Biotechnology, or related field.
Required Experience
- 2–5 years of experience in documentation coordination within pharmaceutical machinery, pharmaceutical manufacturing, validation, or engineering industries.
- Experience in GMP documentation and validation documents preferred.
Pay: ₹25,000.00 - ₹45,000.00 per month
Work Location: In person
