Ipsita Banerjee

Supplier Quality | GMP Compliance | Supplier Qualification | Audits | eQMS | Inspection Readiness Quality Assurance professional with 13+ years of experience in pharmaceutical, biotechnology, medical device, and regulated healthcare industries. Extensive expertise in GMP Quality Systems, supplier qualification programs, supplier audits, quality agreements, discrepancy management, inspection readiness, and regulatory compliance aligned with FDA, ICH, Annex 1, and global GMP requirements. Proven success managing supplier quality programs, supporting health authority inspections, leading audit readiness activities, conducting risk assessments, and collaborating cross-functionally with internal stakeholders and external suppliers to ensure quality, compliance, and continuous improvement.

QA Specialist at Verily (2022-11 – Present)

Manage supplier quality and GMP compliance activities supporting regulated healthcare and biopharmaceutical operations

• Assess and qualify suppliers through review of quality systems, manufacturing processes, technical capabilities, and GMP compliance documentation
• Interface with internal stakeholders and external suppliers/vendors to obtain required quality documentation, supplier records, technical documentation, and quality agreements
• Author, review, negotiate, and maintain supplier quality agreements aligned with GMP and regulatory requirements
• Conduct supplier quality risk assessments and support mitigation strategies to minimize product quality and compliance risks
• Participate in supplier audits, client audits, and internal audit programs to ensure compliance with Bionova/FDA/ICH expectations and GMP requirements
• Support change control, discrepancy investigations, supplier investigations, and CAPA activities within electronic Quality Management Systems (eQMS)
• Maintain inspection readiness by coordinating audit preparation activities, tracking observations, and ensuring timely closure of corrective actions
• Compile quality metrics, trend analysis reports, and compliance data presentations for senior leadership and management reviews
• Collaborate cross-functionally with Procurement, Manufacturing, Regulatory, Quality Control, and external suppliers to drive quality improvements and compliance initiatives
• Support self-inspection programs and health authority inspection readiness activities
• Enforce quality assurance procedures and compliance standards to maintain product quality and regulatory adherence

Quality Assurance Supervisor at Wedgewood Pharmacy (2020-05 – 2022)

Supported GMP quality systems and supplier quality oversight activities within pharmaceutical manufacturing operations

• Managed deviations, CAPA, change controls, investigations, and document control activities
• Supported supplier qualification activities and audit readiness initiatives
• Collaborated with cross-functional teams and vendors to resolve quality issues and improve compliance processes

Quality Assurance Manager at Anresco Laboratories (2019-01 – 2020-05)

Managed ISO-compliant quality systems supporting laboratory and regulated testing operations

• Conducted internal audits, supplier evaluations, and compliance reviews
• Supported discrepancy investigations, CAPA implementation, and quality improvement initiatives

QA Supervisor at Signature Snacks (2014-01 – 2017-03)

Led supplier quality and internal audit programs within regulated manufacturing environment

• Conducted risk assessments, nonconformance investigations, and corrective action activities
• Coordinated supplier communication and quality improvement initiatives

QA Officer at RPG Life Sciences (2012-06 – 2013-12)

Supported pharmaceutical GMP quality systems, documentation management, audit preparation, and compliance activities

• Assisted with supplier documentation review and CAPA implementation

MS in Biotechnology – DY Patil University (2010-07 – 2012-06)

PGDM in Project Management – Fanshawe College (2017-04 – 2018-03)