Global Corporate Quality Systems at Xellia Pharmaceuticals Pvt. Ltd (2024-07 – Present)
- Leading Global Quality Systems and processes.
- Evaluation of global quality processes, identifying areas for improvement, and ultimately driving continuous improvement projects within global quality and business processes.
- Elaborate GMP procedures (API/FDF), quality manual, policies and guidelines to improve Quality Management System (QMS).
- Develop and create process training materials and roll-out plans to all sites.
- Subject Matter Expert (SME) during customer audits/regulatory inspections.
- Responsible for global training programs, webinars and QMS surveys.
- Responsible for Global IT systems validation/verification.
- Responsible for QMB and QLT meeting facilitation.
- Supporting Global R&D Quality.
- Process owner of LMS, My process and Track wise.
Deputy Manager Quality Control at BIOCON BIOLOGICS LIMITED (2020-06 – 2024-07)
- Leading raw material and water analysis team, ensuring quality and compliance.
- Oversees Quality Management System, audits, and compliance activities.
- Directed analytical verification, validation, feasibility studies, and document management.
- Managed QMS events, including OOS, CAPA, and deviations, with timely closure.
- Planned, monitored, and completed raw material and consumables within deadlines.
- Prepared and validated laboratory instruments and protocols.
- Conducted risk assessments, impact analyses, and training programs.
- Reviewed analytical raw data, instrument audit trails, and inspection plans via SAP.
- Created, reviewed, and updated SOPs.
Team Leader Quality Control at STRIDES PHARMA SCIENCE LIMITED (2015-01 – 2020-05)
- Managed raw material and stability sample analysis, ensuring timely completion.
- Investigated and closed QMS events (OOS, OOT, CAPA, deviations) via TrackWise.
- Monitored lab activities and adherence to SOPs across functional areas.
- Reviewed analytical raw data and stability protocols in LIMS.
- Tracked and compiled stability data using SSM and coordinated sample outsourcing.
- Prepared, reviewed, and updated SOPs and ensured regulatory audit compliance.
- Coordinated self-inspections to evaluate quality system effectiveness.
- Implemented training programs and ensured regulatory adherence.
Officer Quality Control at MEDREICH LIMITED (2010-10 – 2014-12)
- Conducted analysis of tablets and capsules across manufacturing stages as per USP/BP/EP standards and stability studies.
- Reviewed quality control documents and external lab reports.
- Managed stability chambers, including maintenance, incubation, and sample withdrawal, using Pharmatech, Thermolab, and Neutronic software.
- Prepared stability protocols and maintained chemical standards, glassware, and columns via SAP.
- Oversaw calibration, qualification, and requalification of lab instruments.
- Conducted GMP training and evaluated its effectiveness.
- Ensured timely batch releases with complete documentation.
- Prepared and reviewed SOPs, protocols, and reports.
Quality Management staff at CIPLA LIMITED (2008-06 – 2010-09)
- Performed analysis of tablets across manufacturing stages and stability studies.
- Reviewed quality control documents and ensured compliance.
- Managed calibration, qualification, and requalification of lab instruments.
- Prepared and reviewed SOPs, protocols, and reports.
- Coordinated periodic self-inspections to ensure adherence to quality standards.
