Executive, Manufacturing Injectables-QMS

  • Job Summary
  • Detail-oriented and compliance-driven Production QMS Executive with experience in sterile / injectable pharmaceutical manufacturing. The candidate will be responsible for ensuring adherence to cGMP, maintaining robust documentation practices, and supporting quality systems within the production function.

Key Responsibilities QMS & Documentation

  • Ensure implementation and compliance with cGMP, GDP, and regulatory requirements in production areas.
  • Preparation, review, and control of:
  • SOPs (Standard Operating Procedures)
  • BMRs (Batch Manufacturing Records)
  • Formats, logbooks, and protocols
  • Handle document lifecycle management (issuance, revision, archival).

Deviation, CAPA & Change Control

  • Initiate, investigate, and close deviations in coordination with QA.
  • Support CAPA (Corrective and Preventive Action) implementation and effectiveness checks.
  • Participate in Change Control processes impacting production.

Production Support

  • Ensure line clearance, in-process checks, and compliance during batch execution.
  • Monitor adherence to aseptic practices and sterile operations.
  • Review batch records before submission to QA.

Audit & Compliance

  • Support internal, external, and regulatory audits (e.g., USFDA, MHRA, WHO).
  • Ensure audit readiness of production documents and areas.
  • Track and close audit observations.

Training & Qualification

  • Conduct and coordinate GMP and SOP training for production staff.
  • Maintain training records and compliance status.
  • Support qualification activities (equipment, process validation documentation).

Data Integrity & Risk Management

  • Ensure adherence to ALCOA+ principles (data integrity).
  • Participate in risk assessments (QRM).
  • Identify and implement continuous improvement initiatives.

Required Skills

  • Strong knowledge of cGMP, aseptic processing, and regulatory guidelines - expert 
  • Experience with QMS systems (Deviation, CAPA, Change Control, OOS/OOT) - expert 
  • Excellent documentation and review skills - expert 
  • Familiarity with data integrity (ALCOA+) principles - expert 
  • Good understanding of sterile manufacturing processes - expert 
  • Strong analytical and problem-solving abilities - expert 
  • Effective communication and cross-functional coordination - expert 
  • Audit handling exposure preferred - expert 

Qualifications

Educational Qualification: B. Sc / M. Sc / B. Pharma / M. Pharma 

Experience: 5-7 Years. 

Note: Candidates who want to apply for internal jobs, must have completed at least 2 years within existing role.

 

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