About this role
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.
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 Executive, QA Validation is responsible for reviewing and preparing validation protocols and reports, coordinating qualification activities, and ensuring compliance with cGMP standards. The role also involves conducting risk assessments and preparing documentation related to quality assurance.
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