Divya Krishnakumar Email & Phone Number

India

* Implement India Quality Management System to align to Global Smiths Medical Quality Management System* Support monitoring of emerging and changing external requirements and guidance in order to maintain global QMS alignment and Local regulation relevance.* Lead and conduct Management review meeting.* Participate in Leadership monthly Functional review meeting to provide Quality input on cross-functional initiatives and provide updates on Quality items, issues and concerns* Conduct Internal audit for Affiliate site in China as per NMPA regulations* Lead Business Model Transition from QMS standpoint post acquisition by ICU Medical* Ensure timely supply chain quality oversight/support and execute product Hold and release activities in timely manner* Coordinate with and periodically check compliance of customs bonded warehouse for MRP labeling operations for goods imported into India.* Manage India complaints process, facilitate complaint sample processing and customer communications as required. Raise trends to global/ manufacturing site* Ensure compliance to Legal Metrology Rules for Import Labels* Manage Quality Operations for Customs Bonded Warehouse* Ensure that Recalls and/or field notifications impacting India and ASEAN countries in scope are executed in a timely & accurate manner.* Host Internal audits at Site and ensure maintenance of compliance and submission of responses to audit inquiries as per determined timelines* Develop quality plans and objectives to ensure India compliance with Global quality strategyImplemented training system in India for 100+ employees and conducted trainings and effectiveness check.* Establish Training system at India location and train associates on global procedures and check effectiveness

Associated Capsules Pvt. Ltd.

Audits and compliance (ISO 9001:2015 Lead Auditor, Qualified GMP Auditor)● Internal auditor● Drive QMS and GMP certification audits across facilities– ISO 9001, EXCiPACT GMP, MFDS Korea (Support) WHO GMP(Support)● Customer audit and compliance trackingSupplier Management● Supplier Audits and compliance● Supplier performance assessment Risk Assessment● Process Risk Assessment - FMEA, Ishikawa, HACCP● Supply Chain risk assessment● Assisting on Business Continuity PlanTraining (Qualified Prashikshak)● Technical trainings – QMS & GMP● Semi-technical trainings – Audit handling, behavior changes for complianceAgreements● Quality technical agreements – designing, review, and completion for Customer, Suppliers, Distributor, Warehouse, Contract Service Providers● Commercial agreements – reviewQuality Management● System and SOP designing, implementation and handling of core QMS principles: CAPA, Change Control, Risk assessment, Supplier Qualification, Quality Metrics, Product Withdrawal● Cost of Non-Compliance – Cost of Poor Quality: ● Designing of Quality manual for ACG Capsules● Quality Metrics ● Gap assessment of sites w.r.t to compliance to regulatory requirement for GMP

Aurangabad Area, India

Interned in the Quality Assurance department - Document Control

Master Of Business Administration - Mba, Quality Management

Master’S Degree, Quality Assurance, A+

Bachelor'S Degree, Pharmaceutical Sciences, A

Schooling From 1St Grade To 12Th Grade