<ul><li>Review of documents like validation protocols, validation reports along with LNBs, verification reports, query reports, LNBs, Specifications, SOPs/GTPs/ Guidelines, calibration reports, Instrument qualification documents, Analyst qualifications, Site master file, Organograms, Job descriptions, Site layouts, etc.</li><li>PDRs Review.</li><li>Reviewing and releasing of plant samples - analytical data &amp; reports and perform audit trail.</li><li>Quality management systems like handling of change controls, CAPA, Internal audits, trainings.</li><li>Preparation of DQA SOPs/Guidelines etc, as per requirement.</li><li>Execution &amp; Review of Computerized System validations &amp; System audit trials.</li><li>Compliance of GLP activities.</li><li>Conducting internal audit and imparting GMP training at APLRC-II.</li></ul>

Assistant Manager Development Quality Assurance