Job Summary
JOB DESCRIPTION
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.
