Production-QMS

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.

Required Skills:

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