Responsibility of Quality Assurance functions. Skilled in managing qualification & re-qualification of equipment,OOS,preparation of SOP,in-process activity, BMR verification, review of analytical data & validation protocols & reports. SOP preparation
Faced regulatory audits by USFDA, MHRA, EU.
Handling of Laboratory investigations like OOS, OOT, Laboratory events & trending. Conducting training to the employees on departmental SOP's, cGMP & current guidelines. Execution of process validations.