
Shashikanth Diddi
- Competent in GMP, GAMP, Data Integrity, 21 CFR Part 11, EU Annex – 11 guidelines. - Adept in... | Aurobindo Pharma, Galaxy, India
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Shashikanth Diddi’s Emails sh****@sy****.com
Shashikanth Diddi’s Phone Numbers No phone number available.
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Shashikanth Diddi’s Location Aurobindo Pharma, Galaxy, India
Shashikanth Diddi’s Expertise - Competent in GMP, GAMP, Data Integrity, 21 CFR Part 11, EU Annex – 11 guidelines. - Adept in validation of the computer systems based on CAPA, FDA regulations and GxP guidelines, and SOPs. - Skilled at Computerized System Validation of Enterprise & Standalone Computerized Systems,Facilities, Equipment, Utilities, etc. - Rich experience in implementation of models for optimal utilization of resources, cost reduction plans, continuous improvements & facility renovations for projects in compliance with regulatory guidelines like US FDA, FIMEA, ANVISA, EU GMP & WHO. - Providing technical support to the CSV team and training a team of Equipment Validation engineers for validation deliverables, change control, system impact assessment, risk assessment, traceability matrix, validation summary report, coordination, and ensuring adherence with organizational objectives, and regulatory compliance requirements. - Proficiency in providing desired operational support like project and operational activities of GxP systems, approving the GxP impacted changes, Periodic Review Reports & deviations. - Eager to enrich skillset with Manufacturing Execution Systems, Data Analysis, SQL, Data science, Machine Learning, SAS (software), Health informatics, Data validation, and Artificial intelligence/ Machine Learning - Demonstrated strong workability with stakeholders at the highest organizational level.
Shashikanth Diddi’s Current Industry Novartis
Shashikanth
Diddi’s Prior Industry
Aurobindo Pharma
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Syngene International
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Biological E
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Sanofi
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Novartis
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Work Experience

Novartis
Senior Specialist - Qa Ecompliance
Sat Apr 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Sanofi
Specialist - Quality Validations & Compliance
Wed Dec 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Feb 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Aurobindo Pharma
Senior Executive-Qa
Mon Apr 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Nov 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Aurobindo Pharma
Executive-Qa
Tue Aug 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Mar 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Biological E
Senior Executive Qa
Tue Nov 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Aug 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Syngene International
Senior Executive Qa
Tue Apr 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Oct 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Syngene International
Project Trainee - Quality Cgmp (Process)
Sat Jun 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Feb 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Aurobindo Pharma
Senior Executive
— Present