Department
Production – Sterile (Dry Powder Injection)
Job Summary
Responsible for execution and supervision of
dry powder injection manufacturing and
aseptic filling operations, ensuring compliance with
GMP and Quality Management System
(QMS)
requirements.
Key Responsibilities
Manufacturing (Dry Powder Injection)
•
Perform dry powder injection manufacturing activities as per SOPs
•
Ensure proper handling of sterile materials and equipment
•
Maintain cleanroom discipline (Grade A/B/C/D)
•
Support aseptic operations and process validation
Filling Unit Operation
•
Operate and monitor vial filling, stoppering, and capping machines
•
Perform line clearance before and after batch activities
•
Ensure in-process checks during filling operations
•
Troubleshoot basic equipment issues
QMS (Quality Management System)
•
Follow GMP and documentation practices (BMR/BPR entries)
•
Handle deviations, CAPA, and change control (as per role level)
•
Ensure compliance with SOPs and regulatory requirements
•
Participate in internal and external audits
Documentation & Compliance
•
Maintain accurate batch records and logbooks
•
Ensure data integrity and real-time documentation
•
Assist in investigation of deviations and non-conformances
Team & Coordination
•
Coordinate with QA, QC, Engineering, and Warehouse
•
Train junior staff (for Sr. Executive/AM roles)
•
Ensure proper shift handover and communication
Qualifications
B.Pharm / M.Pharm / B.Sc / M.Sc (Chemistry / Microbiology / Biotechnology)
Department
Production – Sterile (Dry Powder Injection)
Job Summary
Responsible for execution and supervision of
dry powder injection manufacturing and
aseptic filling operations, ensuring compliance with
GMP and Quality Management System
(QMS)
requirements.
Key Responsibilities
Manufacturing (Dry Powder Injection)
•
Perform dry powder injection manufacturing activities as per SOPs
•
Ensure proper handling of sterile materials and equipment
•
Maintain cleanroom discipline (Grade A/B/C/D)
•
Support aseptic operations and process validation
Filling Unit Operation
•
Operate and monitor vial filling, stoppering, and capping machines
•
Perform line clearance before and after batch activities
•
Ensure in-process checks during filling operations
•
Troubleshoot basic equipment issues
QMS (Quality Management System)
•
Follow GMP and documentation practices (BMR/BPR entries)
•
Handle deviations, CAPA, and change control (as per role level)
•
Ensure compliance with SOPs and regulatory requirements
•
Participate in internal and external audits
Documentation & Compliance
•
Maintain accurate batch records and logbooks
•
Ensure data integrity and real-time documentation
•
Assist in investigation of deviations and non-conformances
Team & Coordination
•
Coordinate with QA, QC, Engineering, and Warehouse
•
Train junior staff (for Sr. Executive/AM roles)
•
Ensure proper shift handover and communication
Qualifications
B.Pharm / M.Pharm / B.Sc / M.Sc (Chemistry / Microbiology / Biotechnology)