Analyst, responsible for performing Analytical method validation and verification of APIs, Intermediates and Raw materials as mentioned below,Must under go training on relevant SOPs prior to execution of activities. Must under go analyst qualification prior to execution of activities. Ensuring data integrity and Good laboratory practices in every step and complying to procedures. Must have adequate knowledge on handling of software's such as Empower 3 and Caliber LIMS. Executing the Analytical method validation and verification activities as per
the plan and schedule. Selection of samples/batches for executing the Analytical method validation activities. Handling and storage of chromatographic columns, standards, chemicals and reagents. Handling and maintenance of instruments such as HPLC, GC, Balances etc.
Handling of sample workflow through LIMS module, by assuring the online documentation. Handling of laboratory abnormal events through the SOP “Laboratory investigation report (LIR)”. Inform to the supervisor about the abnormalities occurred while performing the validation activities and address through procedure delinated in LIR SOP. Adherence with the cGMP requirement as per the current guidelines and Good laboratory practices in every step and complying to procedures. Adhere the procedure and practices on Environment Health & Safety
policy in the site.