Senior Officer – QA of QC | Sun Pharma | Mohali

Job Description

Roles and Responsibilities:

• Review  of Raw Material/Packaging  Material  /Stability/  Microbiology/  Cleaning Method Validation/ Validation/ Finished Product Analytical data, Certificate of Analysis & related documents.
•  Review and approval of Exhibit Stability Protocols.
•  Preparation and review of validation /pre-validation /commercial/annual addition batch/thermal excursion/additional study stability protocol.
• Approval of additional testing requests (if required).
• Review and approval of ln-Vitro/CU and dissolution sheets.
• Review and approval of Analytical Method Transfer documents.
• Participation in handling OOS, OOT, Investigation and deviations related to Quality Control.

• Review  and  approval  of weekly  and  monthly  software  verification  reports  of Empower3.

• Periodic  verification  of application  software  on computer  systems,  associated with
  laboratory instruments with system administrator.
• Review of lab instruments calibration/preventive  maintenance data.
• Review of Stability test results in NOVATEK software.
• Approval of Certificate of Analysis.
• Review and submission of analytical data to site regulatory affairs.
• To  provide  the  response  of  regulatory  affairs  and  Office  of  data  reliability queries.
• Review  and  approval  of change  control  request,  specification,  standard  test procedure
  and SOP in Documentum Compliance Manager System.

Desired Candidate Profile

Educational Qualification : B.Pharma/M.Pharma with 3 to 6 Yrs. Of working experience

Mandatory USFDA Plant Exposure is required.

Note– Sun Pharma does not seek payment of any kind from prospective candidates for employment with Sun Pharma or authorize any agency or any individual to collect or charge any fees or charges for recruitment. Please be cautious while dealing with any recruitment agency or anyone asking you to pay money representing himself to be representing Sun Pharma.