Bharathi Polasanapalli

Experience

• 

  Dr. Reddy's Laboratories

  May 2006 - Jan 2016

  QA Manager

  • Reviewing the operational practices, identifying the areas of obstruction / quality failures, advising on system and process changes for qualitative improvement• Coordination with the QA / QC personnel at various manufacturing sites for implementation of the current / revised standard testing procedures and specifications for new products• Monitoring the washing, dehydrogenation, filling process (Ampoules, Vials, and Lyophilization), and optical inspection, labeling and packing activities as per written procedures. • Evaluating the operator performance those who performed certain activities related to manufacturing and filling process. • Review and ensuring of filter integrity status and reports.• Monitoring and review of environmental monitoring• Monitoring of in-process quality assurance activities and Analytical assurance activities• To ensure that appropriate standards of cGMP are maintained in all aspects of duties.• Execution and review of performance verification reports of autoclaves, sterilization tunnels, LAFs, and AHUs.• Introducing the analytical method validations to ensure the ongoing stability, re-qualification, environmental monitoring, etc.; preparing specification SOPs and relevant documents; undertaking analytical method validation & related documents• Preparing documentation of the in-house developed analytical methods developed and standard testing procedures and specifications for routine use by QC personnel• Overseeing laboratory operations involving preparation of equipment, products and materials for experiments and surveys; conducting field, site surveys and tests and carrying out various experiments for method development. Show less

• 

  Mylan

  Feb 2016 - Feb 2020

  • Assist the local sites, International sites and regional teams to develop, review, approve, and negotiate technical/quality agreements of OSD/API & Injectable. Coordinate with Legal Dept. for the drafting and issuance of technical/quality agreements.• Manage technical/quality agreements to assure responsibilities of each party are being met.• Liaise with business development groups to assure Quality presence in formation and management of business relationships.• Coordinate with Global Operational Auditing function to assure evaluation of third party contractors have been completed prior to completing agreements. • Manage database and ascertain key performance metrics.• Establish relationship with key Quality and Commercial contacts at third party contractors. • Ensure all time readiness to Quality Compliance at all Mylan India sites. • Supporting all Mylan sites during Regulatory audits.• Effective implementation of Global Quality Policies /Directives across all Mylan sites as part of continual improvement process.• Ensure all time readiness to Quality Compliance at all Mylan India sites. • Supporting all Mylan sites during Regulatory audits.• Review of regulatory Audit compliance reports and CAPA effectiveness.• Planning and conducting Corporate Quality Audits to all Mylan Sites and contract testing laboratories.• Planning and conducting Data Integrity Audits to all Mylan OSD Sites. Show less

  • Senior Manager -Regional Quality Operations

    Mar 2018 - Feb 2020

  • Manager -Regional Quality Operations

    Feb 2016 - Feb 2020
• 

  Novartis India

  Feb 2020 - now

  Quality Assurance Manager