Bhavna Parekh

Vice President of Quality and Regulatory @BioTouch

Princeton, NJ, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jul 2023 — Present

Vice President of Quality and Regulatory @BioTouch

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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

N/A

Udacity

Nanodegree, Executive Artificial Intelligence (AI) for Business Leaders

1987 — 1992

Rutgers University–Newark

Bachelor, Biological Science

1987 — 1989

County College of Morris

Associates, Medical Technology

SKILLS

Design ControlValidationManufacturingQuality AssuranceBiotechnologyQuality SystemPexMedical DevicesCapaSix SigmaGxpQuality AuditingAseptic ProcessingQuality ControlGmpCross-Functional Team LeadershipOperations ManagementChange ControlValue Stream Mapping21 Cfr Part 11Iso StandardsLimsLean ManufacturingSupplier Quality ManagementRegulatory SubmissionsIso 13485IsoPharmaceutical IndustrySopFdaRegulatory AffairsStandard Operating Procedure (Sop)CommercializationQuality ManagementU.s. Food and Drug Administration (Fda)Corrective and Preventive Action (Capa)GlpCleaning ValidationProduct DevelopmentTechnology Transfer

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.

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