Deputy Manager, QA Validation

3 days ago


India Amneal Full time ₹ 8,00,000 - ₹ 12,00,000 per year
Description
  • 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.


Qualifications

Executor Level- Validation for Injectables plant with experience of working in regulated industry including US and/or Europe markets.


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