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Sr. Executive / Executive, QA Validation at Amneal India
Ahmedabad, gujarat, India -
Full Time

Start Date

Immediate

Expiry Date

29 May, 26

Salary

0.0

Posted On

28 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Validation, Qualification, URS Review, Protocol Preparation, Report Review, Equipment Qualification, System Qualification, Facility Qualification, Media Fill, Hold Time Study, SOP Preparation, Change Control Assessment, Deviation Assessment, CAPA, Risk Assessment, cGMP Compliance

Industry

Pharmaceutical Manufacturing

Description
Key Responsibilities:  * Responsible for review of URS, DQ and vendor/ supplier’s documents related to qualification. * Responsible for preparation and review of Validation/ Qualification protocol and report. * Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities. * Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities. * Responsible for preparation and review of media fill and hold time protocol and report. * Responsible for preparation of Standard Operating Procedures of Quality Assurance Department. * Responsible for assessment of Change Control, Deviation, CAPA, Investigation etc. * Responsible to prepare protocols of process validation and cleaning verification/validation. * Responsible to conduct sampling activity as per the protocols (Process validation and clearing validation etc.). * Responsible for preparation, review and execution of risk assessment activity related to equipment/ process/ facility/ system. * Responsible for preparation and updation of Annual Validation Planner. * Responsible for review of the master and executed documents of cross functional team (CFT). * Responsible for review of master batch documents. * Responsible to review the different type planner and calibration certificates. * Responsible to monitor cGMP compliance at shop floor. * 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.
Responsibilities
The role is responsible for managing the entire validation lifecycle, including reviewing documentation like URS and DQ, preparing and executing validation/qualification protocols and reports for equipment, systems, and facilities. This involves coordinating with manufacturing, engineering, and QC teams to ensure timely completion of all qualification and validation activities.