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Senior Officer, QA Validation at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

13 Mar, 26

Salary

0.0

Posted On

13 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Validation, Qualification, Protocol Preparation, Report Review, Change Control, Deviation Assessment, CAPA, Investigation, Sampling Activity, Standard Operating Procedures, Process Validation, Cleaning Validation, Coordination, Documentation Review, Execution

Industry

Pharmaceutical Manufacturing

Description

Responsible for review of URS, DQ and vendor/ suppliers’ 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 cleaning validation etc..)

Responsibilities

The Senior Officer, QA Validation is responsible for reviewing documents related to qualification and preparing validation protocols and reports. They coordinate with various departments to ensure timely completion of qualification and validation activities.