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Assistant Manager, QA Validation at Amneal India
, , India -
Full Time

Start Date

Immediate

Expiry Date

09 Mar, 26

Salary

0.0

Posted On

09 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Knowledge, Validation Methodologies, Risk Management, Communication, Problem-Solving, Decision-Making

Industry

Pharmaceutical Manufacturing

Description
•Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility / Process and Plant utilities. •Responsible to co-ordinate with manufacturing personnel for respective Qualification / Validation / Requalification activity for timely completion of activities. •Responsible for preparation and review of Process Validation protocol and compilation of process validation report. •Responsible for preparation and review of Cleaning Validation protocol and compilation of cleaning validation report. •Responsible for preparation and review of Packaging Validation protocol and compilation of Packaging Validation report. •Responsible to co-ordinate with Quality control and Micro department for sample preparation and testing of Validation / Equipment, Utilities and System qualification / Re-qualification study. •Responsible to conduct sampling activity as per the approved cleaning validation protocol. •Responsible for preparation, review and execution of risk assessment activity related to Equipment / Process / Facility / System. •Responsible for preparation and follow up for collection of data related to Validation Master Plan schedule. •Responsible for preparation / Revision of validation SOP’s pertaining to QA validation department. •Responsible to review of Calibration certificates and reports. •Responsible for review of SOP’s pertaining to other department. •Responsible for preparation and review of investigation report for NOI. •Responsible for carry out Impact assessment for any maintenance activity in equipment/system/area. •Responsible to review of change control and deviation to evaluate validation requirement. Skills : Regulatory Knowledge, Validation Methodologies, Risk Management, Communication & Problem-Solving & Decision-Making
Responsibilities
The Assistant Manager, QA Validation is responsible for executing and reviewing qualification and validation activities for equipment, systems, and processes. This includes coordinating with manufacturing and quality control teams to ensure timely completion of validation activities.