Jaspreet Seth

Background

About Jaspreet Seth

Dynamic professional with proven experience in Quality Systems Regulations, Clinical Research Compliance, College of American Pathologists (CAP) accreditation, Good Clinical Laboratory Practices (GCLP), Quality Assurance, Quality Control, Validations and customer support experience. Five+ years experience in clinical research management and laboratory compliance under 45CFR46 and 32CFR219 (human subject research protection), ICH, GCLP and CAP requirements. Responsible for implementation of GCLP and CAP requirements to the workflow and hosting inspections. Fifteen years of work experience in Life Sciences and Medical Devices with 10+ years of experience in Operations and Quality Control under ISO 13485 and cGMP compliance. Responsible for ISO 9001 implementation and compliance including CAPA, Internal Audits, OOS/ Deviation procedures, Supplier Management System and Training Program. Hosted consecutive annual ISO surveillance audits with no observations or findings. Quality Team leader with proficiency in working within the team and also with cross-functional teams. Ability to work well with people from diverse functions, executive levels, industries, cultures, and personalities. Results oriented with consistent record of exceeding standards and expectations (Recipient of QIAGEN’s 3I Award for 2010 (equivalent to Employee of the Year), recipient of multiple Extra Performance Spot Awards and “outstanding” annual review ratings). Multiple years of supervisory and management experience including, but not limited to hiring personnel, performance reviews and budgeting process Proven Areas of Expertise: • Implementation of GCLP guidelines including Quality Management Plan and CAP requirements for clinical research • Managing compliance to 45CFR46 and ICH; interactions with Institutional Review Boards (IRBs) • ISO 9001 implementation and compliance • ISO 13485: cGMP; TQM; IVD; GLP • Internal and External Audits • Risk Analysis & Risk Management • Implementation of Employee Training Program & Competency Trainer • Budgeting / Funds Management • Out of Specification Investigation, Non-Conformances, Deviations & CAPA • Supplier Management System and SCAR • Creating, maintaining and managing SOPs • QC of Reagents (incl. qPCRs and immunoassays) & consumables (plastics) • Incoming Raw Material QC • Formulation & QC Batch Record Review • Scheduling for QC lab staff/ Annual Reviews • Assay Development and Validation • Technology Transfer and Integration • Biochemistry, Cellular and Molecular Biology lab techniques; including cell and tissue culture