Final QA/Compliance approver for validation processes in the area of Lab, IT, Manufacturing, Cleaning and Packaging together with providing guidance to ensure compliance with local, corporate as well as Regulatory (FDA) requirements. QA Approver for Change Requests and SOPs. Perform as e-Compliance manager for global SAP change management process to review/approve change requests and validation documents. Also served as USP Liaison to facilitate inclusion of testing methods within USP as well as participated in monthly NJPQCA meetings to comment on emerging pharmacopeia standards. Supported Deviation, CAPA and Investigation process. Partnered with validation group to complete re-evaluations on time. Functioned as supportive auditor for local site, supported ERP group during global audit, as well as audited US and global sites to review process validation to confirm compliance with corporate standards. QA approver for decommissioning assets through change control process starting from initiation through final closure.

Managed the lab operations and led team of nine scientists for timely release of drug products. Approved methods and testing monographs to develop LIMS standard, as well as approved analytical records to release finished, stability and validation samples through the lab. Developed self motivated and self directive culture to implemented LEAN lab process with 5S principles which significantly brought the lab-cycle time down from eight days to two days.

Analyzed/qualified pharmaceutical dosage forms through Instrument and wet chemical techniques utilizing LIMS and as a deputy Lab Manager ensured continuous flow of finished/stability drug products. Maintaned all the lab equipment to ensure valid calibrated/qualified state prior to respective usage. Fully supported validation of Laboratory computerized systems through generation and execution of IQ/OQ/PQ protocols as well as developed their training manuals and provided training to all the QC Lab scientists.