Production-QMS – Job Responsibilities

Candidate = 01 (M)

Experience Require = 05 to 06 year

Note: Priority API Experience only

- Ensure production activities comply with *GMP, SOPs, BMR/BPR, and QMS requirements*.
- Prepare, review, and control production-related documents and records.
- Initiate and support *deviation, CAPA, change control, and incident* management.
- Monitor compliance with approved manufacturing processes and procedures.
- Support investigation of process deviations, OOS/OOT, and quality-related issues.
- Ensure proper documentation and *ALCOA+ data-integrity* practices.
- Coordinate with *QA, QC, Production, Engineering, and Warehouse* for QMS activities.
- Support *process validation, cleaning validation, qualification, and risk assessment* activities.
- Track and close QMS actions within defined timelines.




- Support internal, customer, and regulatory audits and ensure compliance with applicable GMP requirements.

. Skillset Required: API Experience, GMP, SOPs, BMR/BPR, QMS requirements, production document control, deviation management, CAPA, change control, incident management, manufacturing process compliance, process deviation investigation, OOS/OOT investigation, quality issue investigation, ALCOA+ data-integrity, coordination with QA, QC, Production, Engineering, Warehouse, process validation, cleaning validation, qualification, risk assessment, QMS action tracking, audit support, regulatory compliance

📌 Production-QMS (India)
🏢 Easebiz Fintech Solutions
📍 India