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QMS Lead at Amneal India
, , India -
Full Time

Start Date

Immediate

Expiry Date

01 Apr, 26

Salary

0.0

Posted On

01 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Quality Management System, Standard Operating Procedures, Document Management, Change Control, Deviations, CAPA, Investigation, QRM, Training, cGMP, GDP, Master Documents, Protocols, Reports, Sterile Manufacturing, Warehouse Management

Industry

Pharmaceutical Manufacturing

Description
• Responsible for preparation, review, revision, control and implementation of standard operating procedures of sterile manufacturing department & warehouse department. • Responsible for preparation & review of the master documents of sterile manufacturing department and warehouse department for Parenteral facility -I, II & III. • Responsible for preparation and review of Protocols and reports based on the requirements. • Responsible for Document management like BMR’s, BPR’s, Master SOP’s etc. • Responsible for the handling (Preparation/Initiation/Execution and Approval) of Change Control, Deviations, CAPA, Investigation, QRM, Protocol, Purchase specification etc. for sterile manufacturing department & warehouse department. • Responsible for the Review and Approval of CFT’s Change Control, Deviations, Investigation, QRM, Protocol, other documents etc. • Responsible to follow cGMP, GDP and discipline in the department and to ensure that all employees follow the same. • Responsible to give training to all the subordinates, technicians and operators of the department. 10• 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. • Responsible to attend the training as per training schedule and to ensure training as per TNI.
Responsibilities
The QMS Lead is responsible for the preparation, review, and implementation of standard operating procedures and master documents for the sterile manufacturing and warehouse departments. They also manage document control and ensure compliance with cGMP and GDP standards.