Assistant General Manager, Manufacturing Injectables at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

14 Jul, 26

Salary

0.0

Posted On

15 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Manufacturing Management, Injectables Production, cGMP, GDP, SOP Development, Batch Manufacturing Record, Aseptic Manufacturing, Terminal Sterilization, CIP/SIP, Quality Compliance, Change Control, CAPA, Production Planning, Team Leadership, Equipment Qualification, Audit Handling

Industry

Pharmaceutical Manufacturing

Description

1.Responsible to maintain Area as per zoning qualification and equipment are in good condition. 2.Responsible for preparation, review, revision, control and implementation of standard operating procedures. 3.Responsible for preparation & review of the master documents of Production. 4.Responsible for preparation and review of Protocols and reports based on the requirements. 5.Responsible for Document management like controlled copies of BMR’s, BPR’s,  SOP’s etc. 6.Responsible for the handling of Change Control, Deviations, CAPA, Investigation etc. 7.Responsible to perform activities during  batch operations like bulk manufacturing, filling, Aseptic manufacturing, Terminal sterilization, CIP/SIP & online leak testing operations. 8.Responsible for preparation of production planning on monthly and also daily as per the requirement and availability of materials. 9.Responsible to prepare daily production report as per the production achieved. 10.Responsible to ensure that all equipment and lines are in qualified state. 11.Responsible to follow cGMP, GDP and discipline in the department and to ensure that all employees follow the same. 12.Responsible to give training to all the subordinates, technicians and operators of the department. 13.Activities other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HOD’s instruction and guidance. 14.Responsible to attend the training as per training schedule and to ensure training as per TNI. 15.Ensure the compliance & discipline on floor. 16.Responsible to make & Review shift schedule of Reporties. 17.Responsible to handle internal and external inspections and explain process, documents to auditor as and when required. 18.Responsible for review of executed BMR, and other reports generated during batch operation and qualification / re-qualification activity.

Responsibilities

The Assistant General Manager is responsible for overseeing manufacturing operations for injectables, including batch production, aseptic processes, and equipment qualification. They must ensure strict adherence to cGMP and GDP standards while managing documentation, training, and internal/external audits.