Sandeep Kumar Sharma

Project Manager- Compliance at PQE Group

Sandeep Kumar Sharma has a diverse range of work experience in pharmaceutical companies, starting from 2008 to the present. Sandeep Kumar began their career as a Production Officer at Mankind Pharma Ltd. and was responsible for supervising unit preparation, manufacturing, and filling operations. Sandeep Kumar also worked on SOP preparation and compliance.

In 2010, Sandeep joined Fresenius Kabi Oncology Ltd. (formerly Dabur Pharma Ltd.) as a Sr. Officer Production. Here, they supervised unit preparation, manufacturing, and online documentation activities. Sandeep Kumar also conducted GAP analysis and implemented mitigation plans as per regulatory agency observations.

Sandeep then joined CIPLA Ltd. in 2013 as a Management Staff. Sandeep Kumar'sresponsibilities included supervising and planning the dispensing, manufacturing, washing, and filling units. Sandeep Kumar also coordinated with cross-functional teams for smooth implementation and worked on continuous improvement initiatives.

In 2014, Sandeep joined Hospira Healthcare Pvt. Ltd. (a Pfizer company) as a Senior Executive in Manufacturing Remediation. Sandeep Kumar'swork involved preparing, reviewing, and closing investigation reports for deviations, equipment failures, and market complaints. Sandeep Kumar also initiated and tracked CAPA actions for maintaining manufacturing and quality KPIs.

From 2015 to 2019, Sandeep worked at Akorn India Pvt. Ltd. as an Assistant Manager. Here, they focused on preparing, reviewing, tracking, and trending quality management system documents. Sandeep Kumar also conducted internal audits and implemented identified mitigation plans.

Currently, Sandeep is working at PQE Group as a Project Manager and Compliance Consultant. Sandeep Kumar'sresponsibilities include activity and resource planning, risk management, strategy formulation, and coordination with cross-functional teams. Sandeep Kumar is also involved in quality procedure and policy improvement, and preparation of regulatory response letters.

Sandeep Kumar Sharma attended Rajasthan University of Health Sciences, Jaipur from 2003 to 2008, where they pursued a Bachelor of Pharmacy (BPharm) degree with a specialization in Pharmacy. Prior to that, they completed their Senior Secondary Examination from the Board of Secondary Education, Rajasthan in 2001, with a focus on Science. Furthermore, they obtained their Secondary Examination certification from the Board of Secondary Education, Rajasthan in 1999. Additionally, Sandeep Kumar Sharma has earned the ASQ Certified Quality Auditor certification from ASQ - World Headquarters in October 2021.

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Timeline

  • Project Manager- Compliance

    April, 2019 - present