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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.
- Good knowledge of production processes in OSD or sterile dosage forms.
- Proficiency in MS Office and QMS software tools (e.g., TrackWise, MasterControl).
- Strong coordination and communication abilities across teams.

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