Quality Management System (Production)

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.