Officer - Production (QA Background) | Parenteral Manufacturing

Role & responsibilities

• Handling e-QMS related activities and documentation.
• Managing LMS training compliance activities.
• Maintaining DMS documentation, version control, and approvals.
• Initiating and managing Change Controls.
• Investigating and closing CAPA within defined timelines.
• Deviation handling, root cause analysis, risk assessment, and closure.
• Ensuring compliance with cGMP, GDP, and regulatory requirements.
• Supporting internal, external, customer, and regulatory audits.
• Coordinating with QA, QC, Engineering, and Regulatory teams for compliance activities.

Preferred candidate profile

• Exposure to Sterile / Aseptic Manufacturing.
• Regulatory inspection and audit handling experience.
• Knowledge of Quality Risk Management (QRM) and FMEA.
• Experience in APQR / Annual Product Quality Review activities.
• Knowledge of e-QMS, LMS, DMS, Change Control, CAPA, Deviations, and PQR.
• Understanding of USFDA, MHRA, WHO-GMP guidelines.
• Good Documentation Practices (GDP).
• Strong communication and coordination skills.