Divya Bale

About Divya Bale

Experienced M. Pharma professional with invaluable expertise in Corporate Quality…

Experience

1. Sr Manager Quality Operations

   Novartis

   Jan 2018 — Present · Hyderabad, IN

   Change Control Management: Platforms supported – Small Molecules (SM), Large Molecules (LM) and Cell and Gene Therapy (CGT)• Core SME in deployment of change control module in 1QEM.• Manage different type of change controls like product stewardship/Administration Stewardship/Asset Stewardship in systems like TrackWise and/or AGILE from Change Initiation to closure as needed• KPI Reporting: Generate and analyze predefined and ad-hoc reports in various applications (such as AGILE PLM, AQWA etc.).• Provide Governance support.• Escalate service related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures.• Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations.• Act as single point of contact for stakeholder management, SLA negotiations.• Lead/transition new service or expansion projects, monitor and report progress and deviations, as appropriate.• Train, develop or mentor personnel for successful and timely onboarding in Quality Operations.• Ensure all time readiness for customer and internal audits and follow up on implementation of agreed CAPAs in the responsible service area.Achievements: • Received APPLAUSE award in recognition of contribution towards operational excellence by on-boarding new site in well ahead of committed time with no escalations.• Received appreciation award for enthusiastically working on predictive ‘Customer Intelligence’ and thus helping the team to achieve better Customer satisfaction.• Received Global Quality Award for Agile deployment across NTO and NCQ_Embrace Operational Excellence Everyday.• Certified BRAC Basic Regulatory Affairs Course (BRAC)• Certified Investigator for Deviations• Certified ISO 9001:2015 Lead Auditor QMS• U-Tech International - Certified GMP Professional

Education

• Jawaharlal Nehru Technological University, Kakinada

  Master's degree, Pharmaceutical Sciences

• Andhra University

  Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences