Sr. Officer To Sr. Executive - Documentation - Production - API Mfg.

Job Title: Senior Officer to Senior Executive QMS (Production)

Section:

We are looking for an experienced QMS professional for our Production Department who will be responsible for ensuring compliance with cGMP, documentation practices, validations, and audit readiness.

Key Responsibilities:

1. Prepare new SOPs and revise existing SOPs as per requirements, periodic updates, and audit recommendations, including review and implementation for the Production department.
2. Carry out process validation and cleaning validation in coordination with R&D, QC, and QA, ensuring acceptance criteria are met for new and existing products.
3. Ensure compliance with cGMP and safety standards in the production area and monitor safe working practices of all subordinates.
4. Maintain plant readiness for internal and external audits. Review audit reports, prepare CAPA, and ensure timely implementation.
5. Monitor temperature, humidity, and differential pressure in clean areas (Level II & III) and ensure proper maintenance and verification of documents like BMR/BPR/BCR as per cGMP/USFDA guidelines.
6. Ensure strict adherence to SOPs and cGMP during all manufacturing operations.
7. Initiate and close online incidents, deviations (planned/unplanned), and change controls with complete supporting documentation.
8. Investigate batch failures (OOS/Incidents/Deviations), identify root causes, prepare reports, recommend CAPA, and ensure CAPA effectiveness.
9. Prepare and review BMR/BPR/BCR for new products and revised batch sizes as per R&D processes and audit/validation/RA requirements.
10. Prepare equipment and process mapping, change summary, equipment/process comparison, risk assessment, errata, quality comparison/equivalency, and process flow diagrams.
11. Maintain updated lists of authorized personnel, organograms, SOP revision lists, and logs for CC/CAPA/Deviation/OOS/Incident/Errata/Product/Equipment details.
12. Prepare and review protocols and reports for area qualification & requalification, calculator validation, excel sheet validation, weighing balance accuracy/precision logs, and intermediate re-analysis.
13. Generate and manage online training through AIMS software in consultation with concerned departments.
14. Provide functional and cross-functional training to new and existing employees as per training needs and document requirements.
15. Prepare LCS (Limit Calculation Sheet) for new/existing products based on validation recommendations for cleaning of equipment.
16. Coordinate with QA, QC, R&D, Warehouse, Engineering, ADL, and RA regarding documentation, product failures, and compliance requirements.
17. Coordinate with QA for documentation issuance/submission and with Warehouse for RM/Intermediate/API issuance.
18. Maintain inventory of plant/process-related consumables as per requirements.
19. Execute batch processing as per SOPs, BMR/BCR/BPR and maintain data in equipment usage logs ensuring accuracy and timeliness.
20. Complete online trainings in AIMS software as per schedule.
21. Record and maintain all documents online in compliance with cGMP.

Key Skills Required:

• Strong knowledge of cGMP, USFDA guidelines
• Expertise in documentation, validations, and quality systems
• Experience in deviation/OOS/incident handling and CAPA management
• Good coordination and communication skills
• Proficiency in SOP preparation, BMR/BPR/BCR review
• Hands-on experience with AIMS or similar training/document management software