ZTMP - QA Investigation

Job Description

Qualification should be M.Sc. Organic chemistry/ PhD with organic chemistry. Person shall be 3-5 year experience in PD Lab/R&D/QA Key Job Responsibilities Handling of the deviation, OOS, OOT, Marketcomplaint, Lab incident, CAPA. Handling of audits and compliance. Shop floor investigation to identify the rootcause. To form CFT for investigation and lead theinvestigation. To review an investigation plan. To provide necessary information and data forthe investigation. To ensure investigation is completed within timeline. If investigation is not completed in time, toensure Interim Report is prepared, reviewed and request for extension isapproved by QA head. To prepare and review investigation report andcause or probable cause for finding cause of failure. Discuss the findings and improvement areas basedon trend analysis in Quality Review Meetings. Preparation, review and approvalof trend analysis reports. Identification of improvement areas based ontrend analysis report and providing feedback to the site management. To propose an investigation plan and evaluationof the impact of failure on already distributed batches, batches undermanufacturing or in staging/ Process area. To find out root cause or contributory factorfor most probable root cause. To carry out impact assessment and riskassessment. To notify the other functional head to carry outinvestigation.