Senior Executive-Manufacturing
Amneal Pharmaceuticals
Date: 2 weeks ago
City: Ahmedabad, Gujarat
Contract type: Full time
Job Description
Responsible for document management like BMRs, BPRs, master SOPs etc..
Responsible for preparation & review of the master documents of production.
Responsible to ensure UAF working in area.
Responsible for the handling of change control, deviations, investigation & CAPA, etc. Responsible for line clearance activity before commencing the operations.
Responsible to check that all the records and logbooks related to manufacturing, Sterilization, washing and sterilization of equipment’s.
Responsible for preparation, review, revision, control, and implementation of standard operating procedures of sterile manufacturing department.
Responsible to ensure cleaning and sanitization of General, Controlled & Aseptic area.
Inform immediately to department functional head for any observation/disturbance with respect to documents and machines found in area.
Responsible for monitoring all the activities related to General, Control & Aseptic area. Aseptic vial/bag filling , Responsible for vial washing , autoclave and terminal sterilization operation.
Skills
Complying with Good Manufacturing Practices (GMP) and regulatory standards (USFDA, MHRA, WHO, etc.).
Completing Batch Packing Records (BPRs), logbooks, and deviation reports.
Maintaining traceability and following SOPs strictly
Qualifications
B.Sc. /M.Sc. / B. Pharm / M.Pharm
Responsible for document management like BMRs, BPRs, master SOPs etc..
Responsible for preparation & review of the master documents of production.
Responsible to ensure UAF working in area.
Responsible for the handling of change control, deviations, investigation & CAPA, etc. Responsible for line clearance activity before commencing the operations.
Responsible to check that all the records and logbooks related to manufacturing, Sterilization, washing and sterilization of equipment’s.
Responsible for preparation, review, revision, control, and implementation of standard operating procedures of sterile manufacturing department.
Responsible to ensure cleaning and sanitization of General, Controlled & Aseptic area.
Inform immediately to department functional head for any observation/disturbance with respect to documents and machines found in area.
Responsible for monitoring all the activities related to General, Control & Aseptic area. Aseptic vial/bag filling , Responsible for vial washing , autoclave and terminal sterilization operation.
Skills
Complying with Good Manufacturing Practices (GMP) and regulatory standards (USFDA, MHRA, WHO, etc.).
Completing Batch Packing Records (BPRs), logbooks, and deviation reports.
Maintaining traceability and following SOPs strictly
Qualifications
B.Sc. /M.Sc. / B. Pharm / M.Pharm
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