Job Description
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.