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Sun Pharma
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Executive-QA of QC (Sun Pharmaceutical Mohali)

Executive-QA of QC (Sun Pharmaceutical Mohali)

Sun Pharma

5 - 8 years

5 - 8 Lacs

Mohali

Posted:2 months ago| Platform:

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Skills Required

usfda SAP Analytical LIMS Validation Testing XRD Dissolution Chromatography

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & 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.

Preferred candidate profile

Educational Qualification : B.Pharma/M.Pharma with 5 to 7 Yrs of working experience

Mandatory USFDA Plant Exposure is required.

Note

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