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Key Responsibilities:
Ensure effective implementation of QMS elements such as deviation, CAPA, change control, and risk assessment in production.
Support production teams in initiating and closing QMS records in a timely manner.
Coordinate with QA and cross-functional teams to ensure proper documentation and follow-up of QMS activities.
Review and maintain SOPs, batch records, logbooks, and ensure compliance with GDP.
Track and follow up on CAPA implementation and effectiveness checks.
Assist in root cause analysis (RCA) for deviations and non-conformances in production.
Prepare data and reports for internal audits, external inspections, and quality review meetings.
Ensure timely closure of audit observations and QMS commitments.
Participate in periodic QMS training, self-inspections,



and continuous improvement initiatives.
Support process validation, qualification documentation, and GMP compliance projects.

Required Skills and Competencies:
Sound understanding of QMS processes (CAPA, deviation, change control, audit handling).
Familiarity with regulatory requirements (cGMP, WHO, MHRA, USFDA, etc.).
Solid documentation skills and attention to detail.
Valuable knowledge of production processes in OSD or sterile dosage forms.
Proficiency in MS Office and QMS software tools (e.g., TrackWise, MasterControl).
Robust coordination and communication abilities across teams.

📌 Quality Management System Production Amreli (India)
🏢 Pramukh Staffing
📍 India