Job Description:
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.).
• Strong 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.