Manager, Manufacturing Injectables

Essential Functions:

• Responsible for preparation, review, revision, control, and implementation of standard operating procedures .
• Responsible for preparation & review of the master documents of production .
• Responsible for preparation and review of Protocols and reports based on the requirements.
• Responsible for Document management like BMRs, BPRs, Master SOPs etc..
• Responsible for the handling of Change Control, Deviations, CAPA, Investigation etc..
• Responsible for line clearance activity before commencing the operations like manufacturing, filling, capping & packing operations .
• To generate general purchase indent for departmental general items.
• Responsible for preparation of production planning on monthly and daily as per the requirement and availability of materials.
• Responsible to prepare daily production report as per the production achieved.
• Responsible to ensure that all equipment’s and lines are in validated and calibrated status.
• Responsible to follow cGMP, GDP, and discipline in the department and to ensure that all employees follow the same.
• Ensure the compliance & discipline .
• Responsible to makeshift schedule .
Responsible to check that all the records and logbooks related to manufacturing, filling and sterilization of equipment’s

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.

Education:

• Bachelors Degree (BA/BS) B. Sc. - Required
• Bachelors Degree (BA/BS) B. Pharm - Preferred
• Master Degree (MS/MA) M. Pharm - Preferred

Experience:

• 12 years or more in 12 - 16 Yrs

Skills:

• Depyrogenation -Operation of depyrogenation tunnel supplied - Intermediate
• Filling, stoppering and sealing - Operation of glass vial/bottle filling and stoppering machine - Intermediate
• CIP & SIP - Operating skill for CIP/SIP skids - Proficient
• Dispensing - Handling and dispensing procedure for different type of materials - Proficient
• Sterilization Process by Autoclave - Proficient
• Mixing - Operation of mixing vessels - Intermediate
• Decartoning - Technique for Loading of glass vial / bottle - Intermediate
• Washing - Operation of glass vial/bottle washing machine supplied - Intermediate
• GMP Compliance & Documentation - Adhering to Good Manufacturing Practices (GMP) and regulatory norms (USFDA, EU, WHO) - Intermediate
• Filtration - Operation of filtration vessels supplied - Intermediate
• Managing lyophilization cycles to enhance product stability - Proficient
• Accurate and detailed record-keeping of every step in the injectable packing process - Proficient
• Ensuring all packing equipment is calibrated and working within required parameters - Proficient
• Identifying and resolving issues with packing equipment, ensuring minimal downtime - Proficient
• Operating and handling packing machines to ensure smooth production of injectable products - Proficient
• GMP Compliance & Documentation - Adhering to Good Manufacturing Practices (GMP) and regulatory norms (USFDA, EU, WHO) - Proficient
• Packing - Intermediate
• People Management - Proficient
• Leadership Skill - Proficient
• Trouble Shooting/ Problem solving skill - Proficient

Specialized Knowledge: Licenses: