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