The candidate should have experience in
IVRT and IVPT studies
, as well as exposure to the
Bioanalytical segment
, preferably within the
Quality Assurance or Operations department along with below job profile.
To prepare and review the quality management system related documents like quality manual, SOPs etc. including review of technical SOPs.
To plan and perform system audits and study audits of IVRT & IVPT or In-vitro studies to ensure compliance of approved documents.
To review the study and/or project related documents like protocol, raw data, report, STP etc. for adequacy and accuracy.
To review quality tools like incidents, change controls, deviations, OOS, CAPA, repeat analysis as per respective SOP.
To review instrument qualification, calibration certificates and computerized system validation documents.
To impart training on quality management system related documents like SOPs, quality policy etc.
To issue and control documents as per document management system.
To ensure computerized systems used for any stage of analysis are in validated state and relevant electronic data along with audit trails are reviewed.
To face regulatory and or sponsor audit and involve in preparation of response for submission to regulatory agency and/or sponsor within time frame.
To perform Sample retention related activities in absence of lab-coordinator/Pharmacist.
Any Additional responsibilities given by Department In-Charge / Management.
