Bhavna Parekh

About Bhavna Parekh

Accomplished Quality leader with comprehensive Quality, Compliance, Regulatory, Technology Transfer and Manufacturing experience within the Medical Device, Pharmaceutical and Consumer Industry. Proven record in improving compliance, simplifying and building quality systems and processes using agile tools and managing global programs and projects. Strong background in Audits, Remediation, Design Controls, Combination Products, Devices, OTC, Cosmetics and Dietary Supplements, with delivering Best in Class products to the market. Extensive knowledge of cGMP, FDA, ICH and ISO requirements and proven background in regulatory audit facilitation. Solid background in staff development. Specialties: Quality and Compliance, Manufacturing Site Management, Laboratory Management, Regulatory Compliance, Technology Transfer, Operations Management, Change Management, Design Controls, Technical Product Support, People Management, Audits, Remediation, Risk Assessments, Acquisition and Divestiture.

Experience

1. Vice President of Quality and Regulatory

   BioTouch

   Jul 2023 — Present

   Provide strategic leadership across the global Quality Teams, who support the E2E printing, packaging, kitting, and logistics at BioTouch. Implement strategies to ensure product quality and adherence to regulatory standards. Responsible in building a global eQMS system which will result in standardization of processes and systems.Support and drive operational excellence with a Quality and Compliance lens.

Education

• Udacity

  Nanodegree, Executive Artificial Intelligence (AI) for Business Leaders

• Rutgers University–Newark

  Bachelor, Biological Science

  1987 — 1992

• County College of Morris

  Associates, Medical Technology

  1987 — 1989

Skills

• Design Control
• Validation
• Manufacturing
• Quality Assurance
• Biotechnology
• Quality System
• Pex
• Medical Devices
• Capa
• Six Sigma
• Gxp
• Quality Auditing
• Aseptic Processing
• Quality Control
• Gmp
• Cross-Functional Team Leadership
• Operations Management
• Change Control
• Value Stream Mapping
• 21 Cfr Part 11
• Iso Standards
• Lims
• Lean Manufacturing
• Supplier Quality Management
• Regulatory Submissions
• Iso 13485
• Iso
• Pharmaceutical Industry
• Sop
• Fda
• Regulatory Affairs
• Standard Operating Procedure (Sop)
• Commercialization
• Quality Management
• U.s. Food and Drug Administration (Fda)
• Corrective and Preventive Action (Capa)
• Glp
• Cleaning Validation
• Product Development
• Technology Transfer