Trackwise
ANJALI MISHRA
Senior Supplier Quality Executive
Bengaluru,KA
Summary
Goal driven Quality Assurance Professional with 4+ years of experience seeking opportunity in Supplier Qualification, Audit management, Supplier Change Notification and leading Quality Projects.
Overview
5
5
years of professional experience
5
5
years of post-secondary education
1
1
Certification
2
2
Languages
Work History
Senior Supplier Quality Executive
Biocon Biologics Limited
Bangalore, KA
07.2021 - Current
- Qualification and Evaluation of Suppliers as per Supplier Quality Management Procedures.
- Develop relationship and partnership across multiple facilities, departments like SCM, Production, Device Technology and Principle management, Program management, R&D, Packaging, Quality Control, Regulatory and Partners.
- Perform periodic quality audits of suppliers to assure continued Supplier conformance as per Quality system requirements.
- Create and maintain strong relationship and communication between supply chain management and Suppliers.
- Initiate and follow-up the Supplier Quality Audit CAPAs to assure complete and effective root cause analysis and corrective and preventive action implementation.
- Evaluate, initiate, approve and closure of the supplier change notification within the target implementation date of respective change through change control process.
- Perform Annual Monitoring of suppliers with the collaboration of cross functional team to assure the continue supply of Quality material for the continuation of manufacturing.
- Lead cross- functional projects with concise and clear plans that consistently give the fruitful output to achieve the set targets.
- Prepare and finalize the Quality agreements with suppliers.
- Resolve quality issues, material discrepancies, supplier complaints, OOS, deviation, investigation within effective timelines.
Supplier Quality Executive - CQA
Biocon Biologics Limited
Bangalore, KA
10.2017 - 06.2021
- Qualification and Evaluation of Suppliers and materials.
- Maintained supplier approve list and service provider approved lists for multiple plants and facilities.
- Prepared and Maintained Annual supplier/service provider audit planner as per the quality procedure.
- Coordinated with SCM for the availability of audit dates to conducted the supplier audits.
- Maintained quality audit CAPA logbook for the effective ontime closures.
- Prepared and shared Audit Agendas with SCM and supplier.
- Maintained log books of Quality Agreement, Test Release Form, Supplier Intimation Form, Supplier qualification, Service Provider, Quality Audit Reports, Change Control, Deviation, SOP Index.
- Drafted Audit Report, Audit Response, Change Controls for the finalization.
- Maintained Quality Info Records in SAP.
- Follow-up for Supplier Change Controls.
Education
M.Sc. - Biotechnology
Banasthali University
Jaipur 07.2014 - 06.2016
B.Sc. - Biotechnology
Kanpur University
Kanpur 07.2011 - 06.2014
Skills
Microsoft Office
21 CFR Part 11
Planning and Management
21 CFR 820
ISO 13485:2017
Regulation (EU) 2017/745
Communication and Follow-up
Trackwise
Learning Management Suite
Filenet
Leadership
Accomplishments
- M.Sc
- (Biotechnology) Dissertation Project completed from DRDO, DIBER, Haldwani, UK
- India on Invitro regeneration of chenopodium quinoa and breaking seed dormancy of Hippophae salcifolia by different chemical treatments
- Hands on industrial training from Helix Biogenesis
Software
Microsoft Office
SAP
Filenet
Minitab
Certification
Biocon-KGI Certificate Program
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
The road to success and the road to failure are almost exactly the same.
Colin R. Davis
Timeline
Senior Supplier Quality Executive
Biocon Biologics Limited
07.2021 - Current
Supplier Quality Executive - CQA
Biocon Biologics Limited
10.2017 - 06.2021
Biocon-KGI Certificate Program
03-2017
M.Sc. - Biotechnology
Banasthali University
07.2014 - 06.2016
B.Sc. - Biotechnology
Kanpur University
07.2011 - 06.2014