Description:
The role involves supervising aseptic manufacturing activities, ensuring adherence to GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices) across General, Control, and Aseptic areas. The position is accountable for equipment and line validation status, change control, deviation management, and CAPA (Corrective and Preventive Action) implementation. The role also leads SOP (Standard Operating Procedure) lifecycle management, production planning versus actual performance monitoring, and regulatory readiness. Additionally, the role requires maintaining accurate online documentation systems and aligning operations with USFDA (United States Food and Drug Administration) and ICH (International Council for Harmonisation) requirements.
Essential Functions:
- Ensure and monitor all GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices) activities, including cleaning and sanitization, across General, Control, and Aseptic areas
- Supervise overall injectable manufacturing operations during assigned shifts, ensuring aseptic compliance
- Ensure all equipment and manufacturing lines are validated and calibrated as per approved schedules
- Generate and track general purchase indents for departmental consumables and production items
- Handle Change Control, Deviations, Investigations, and CAPA (Corrective and Preventive Action) in coordination with QA
- Prepare, review, revise, control, and implement SOPs (Standard Operating Procedures) for sterile manufacturing operations
- Prepare production plan vs actual reports on daily and monthly basis based on material availability
- Ensure strict adherence to aseptic techniques and sterilization processes during injectable manufacturing
- Monitor CPPs (Critical Process Parameters) and CQAs (Critical Quality Attributes) during batch execution
- Support internal and external audits and ensure compliance with USFDA and ICH guidelines
- Responsible for preparation & review of the all-master documents of production
- Responsible to update on self-hygiene
- Responsible to attend the training as per training schedule and to ensure training of the team as per TNI
Additional Responsibilities:
- Responsible to give training to all the subordinates, technicians, and operators of the department.
- Activities other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance.
- Responsible to attend the training as per training schedule and to ensure training as per TNI.
Qualifications
Education: B. Pharm - Required / M. Pharm - Preferred
Experience: minimum Experience 12 Years in injectable plant
