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.

• 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).

• 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.

• 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.

• Support internal, external, and regulatory audits (e.g., USFDA, MHRA, WHO).


• Ensure audit readiness of production documents and areas.


• Track and close audit observations.

• Conduct and coordinate GMP and SOP training for production staff.


• Maintain training records and compliance status.


• Support qualification activities (equipment, process validation documentation).

• Ensure adherence to ALCOA+ principles (data integrity).


• Participate in risk assessments (QRM).


• Identify and implement continuous improvement initiatives.

• 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