Manager, Manufacturing Injectables
Amneal Pharmaceuticals
- Experience
- 12+ yrs
- Location
- Ahmedabad, Gujarat, India
- Job type
- Full-time
About the role
Description:The role involves ensuring CGMP compliance and supervising overall production activities of manufacturing area of assigned manufacturing line. Additionally, the position requires reviewing and maintaining online documents.
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.
Qualifications
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
Specialized Knowledge: Licenses:
About Amneal Pharmaceuticals
Develops and manufactures generic and specialty pharmaceutical products.
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