About this role
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..)
Other facts
About Amneal
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
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Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
What you'll do
- The Senior Officer, QA Validation is responsible for reviewing various qualification documents and preparing validation protocols and reports. They coordinate with multiple departments to ensure timely completion of qualification and validation activities.
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