Sagar Navale

About Sagar Navale

Focused & goal driven with strong work ethics, continuously striving for improvement…

Experience

1. Quality Assurance Manager

   Abbott

   Dec 2022 — Present · Mumbai, IN

   Leading Quality management system for Abbott diabetes care, India by ensuring compliance to supplier management, distributor management, local SOP management, Adverse event reporting, regulatory compliance, internal and external Audits, deviations, field actions, change control, and CAPAs. • Leading and/or participating in audits evaluating the adequacy of controls for key business processes, including:• Preparing audit schedules for suppliers of various categories associated with the business. • Preparing audit plans for scheduled and assigned audits. • Arranging and reviewing of pre-audit documentation before an onsite audit.• Contacting auditee to agree on audit dates and ensuring audit timelines are followed to ensure schedules audits carry on schedule. • Entering and categorizing audit/inspection findings in eQMS. • Soliciting follow-up information and closing audit/inspection findings in the QA database. • Review and approval of corrective and preventive actions (CAPA) and effectiveness check (EC) Plans. • Assist in hosting customer audits, mock regulatory inspections, and regulatory facility inspections by acting as a scribe. Reviewing documents, identifying and calling operational staff to answer related questions. • Maintains the electronic quality management system eQMS and provides support in relation to the audit lifecycle. • Assisting in the development of an Internal audit approach and testing strategy for assigned audit projects to ensure all key business risks and controls are evaluated. • Understanding and interpreting EU MDR/ IVDR in its current form and continuously ongoing related changes. • Responsible for audits and gaps analysis towards MRD 2017 compliance and providing actionable intelligence to implement global regulatory and quality plans to meet the goals in defined timelines.

Education

• University of Pune

  Master's Degree

  2011 — 2013

• University of Mumbai

  Bachelor's Degree

  2006 — 2009

Skills

• Regulatory Affairs
• Sop
• Validation
• Hplc
• V&V
• Cleaning Validation
• Technology Transfer
• Gmp
• Pharmaceutical Industry
• Formulation
• Pharmaceutics
• Team Management
• R&D
• Quality System
• Glp
• Biotechnology
• Fda
• Life Sciences
• Drug Delivery
• Dissolution
• Quality Assurance
• Chromatography