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.
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
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