Dinky Dave

Quality Assurance and Compliance Professional with over 6 years of experience across Pharmaceutical and Medical Device industries. Experienced in Quality Management Systems (QMS), Internal Auditing, Change Control, Deviation Management, CAPA, Batch Release, Process Validation, Regulatory Compliance and Documentation Management. Currently working in the Medical Device industry with hands-on exposure to ISO 13485 requirements, Internal Quality Audits, Management Review Meetings, Quality Management Meetings and Site Master File maintenance.

Certified Lead

Auditor with strong knowledge of quality systems, regulatory requirements and continuous improvement principles. Seeking to leverage auditing, compliance and quality management expertise in a Medical Device Assessor / Lead Auditor role.

QA Executive – Medical Devices - MERIL MEDICAL INNOVATIONS PVT. LTD.

(2026-03)

• Manage Quality Management System activities in accordance with ISO 13485 requirements.
• Handle Change Controls, Deviations, Non conformities and CAPA activities.
• Coordinate and conduct Internal Quality Audits across departments.
• Participate in audit planning, execution, reporting and effectiveness verification.
• Support Management Review Meetings (MRM) and Quality Management Meetings (QMM).
• Maintain and update Site Master File (SMF) and quality documentation.
• Monitor compliance of quality processes and support continuous improvement initiatives.
• Collaborate with cross-functional teams to ensure regulatory and quality compliance.
• Support external audits and inspection readiness activities.
• Apply risk-based thinking in quality system implementation and maintenance.

QA Officer - SUN PHARMACEUTICAL INDUSTRIES LTD.

(2022-09 - 2026-01)

Reference:-Mr.Sunil Patel-+919879593105

• Led Batch Review and Batch Release activities ensuring compliance with GMP requirements.
• Global Quality and Compliance Responsibilities-Batch Certification & Investigation review.
• Managed Change Controls, SOP revisions and quality documentation lifecycle.
• Performed Annual Product Quality Reviews (APQR).
• Supported Process Validation and Qualification activities.
• Ensured compliance with FDA, EMA and applicable regulatory expectations.
• Coordinated cross-functional quality investigations and compliance activities.
• Consistently achieved timely batch certification and release targets.

Assistant Production Supervisor - MEDLEY PHARMACEUTICALS PVT. LTD.

(2019-09 - 2022-09)

Reference:-Mr.Prashant Desai-+917226853540

• Supervised manufacturing operations in compliance with GMP requirements.
• Coordinated production activities with QA and planning teams.
• Supported change management and process improvement initiatives.
• Ensured adherence to approved procedures and quality standards.

Bachelor of Pharmacy - Pharmacy - Smt. B.N.B. Swaminarayan Pharmacy College, Salvav, Vapi (2019-06)

Higher Secondary Certificate (HSC) - Shree Swaminarayan English Medium School, Salvav (2015)

Secondary School Certificate (SSC) - Shree Swaminarayan English Medium School, Salvav (2013)