Sandeep Kumar Sharma

About Sandeep Kumar Sharma

With a strong foundation as a Project Manager- Compliance at PQE Group, my proficiency in…

Experience

1. Project Manager- Compliance

   PQE Group

   Apr 2019 — Present · IN

   During the tenure worked for client engaged in Parenteral drug manufacturing, API synthesis, Biopharmaceutical and R&D work.As a Project Manager and Consultant responsible for;• Activity and resource planning, analyzing and managing project risk, monitoring and reporting progress, strategy formulation, organizing and motivating a project team, coordination with client cross functional team and status reporting to corporate team with bottle necks.• Review, gap assessment and improvisation of quality procedure and policies, quality management system document, equipment and utility qualification document and process validation.• Preparation and review of USFDA and EDQM and FDA OPMA letter response preparation.• Audit CAPA compliance and action tracking. Preparation and support of audit CAPA effectiveness check verification.• Assessment, preparation and review of site data integrity assessment and pFMEA, cross contamination risk assessment.• Review of batch record followed by RFT matrix assessment to improvise the documentation and quality standards for product batch release.• APQR development and review.• Audit readiness and customer audit support of client.• Mock Inspection/ Internal audit of facility and system to ensure the GMP requirement and compliance for manufacturing resumption and, guidance and implementation support of identified actions.As an Auditor responsible for:• Member of third party audit team, responsible for due-diligence, system, product and follow-up audits. • Audit agenda and audit plan preparation based scope of audit.• Communication with auditee, client and third party audit team.• Risk based auditing as per audit plan and previous audit CAPA follow-up, reporting of observation and findings and communication with auditee, client and third party team.• Evaluation of corrective and preventive action response for adequacy, appropriate root cause and timelines.

Education

• Board of Secondary Education, Rajasthan

  Secondary Examination

  1999

• Rajasthan University of Health Sciences, Jaipur

  Bachelor of Pharmacy - BPharm

  2003 — 2008

• Board of Secondary Education, Rajasthan

  Senior Secondary Examination

  2001