
Sudhir Pandey
· Strategic Leader + 19 years of experience in managing overall Quality Assurance functions in pharmaceutical industry. · Impressive success... | Ahmedabad, Ahmedabad, India
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Sudhir Pandey’s Emails su****@ba****.com
Sudhir Pandey’s Phone Numbers 1847948****
Social Media
Sudhir Pandey’s Location Ahmedabad, Ahmedabad, India
Sudhir Pandey’s Expertise · Strategic Leader + 19 years of experience in managing overall Quality Assurance functions in pharmaceutical industry. · Impressive success in implementing various standards to improve the Product Quality, Deviations, Change Control, CAPA, OOS, Market Complaint, and Failure Investigations, monitoring & measuring performance and driving process re-engineering initiatives · Successfully managed Quality Assurance methodologies including IPQA, QMS and Regulatory compliance for the manufacturing of Pharmaceutical Products · Experience in QMS, IPQA ,Commercial Manufacturing & Regulatory Submission · Played a key role in Regulatory GMP Audits, Global Audit / CQA and many more customer/semi regulatory audits. · Highly skilled in ensuring compliance to quality and regulatory measures by maintaining appropriate documentation/records and analyzing sources of quality data and identifying quality issues. · Preparation of Audit Strategy, SME readiness, Audit Management and Active participation in writing of compliance against identified observation and shared with USFDA. · Compliance & Commitment tracking and effectively implementation of Regulatory Agency. · Review and preparedness of USFDA audits in coordination with CFTs and SMEs interaction
Sudhir Pandey’s Current Industry Baxter International
Sudhir
Pandey’s Prior Industry
Baxter International
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Ind Swift
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Glenmark Pharmaceuticals
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Lupin
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Intas Pharmaceuticals
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Sun Pharma
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Healthkart
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Acme Generics
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Windlas Biotech
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Work Experience

Baxter International
Senior Quality Assurance Specialist
Mon Feb 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Windlas Biotech
Senior Quality Assurance Manager
Sun Mar 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Feb 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Acme Generics
Quality Assurance Manager
Thu Jun 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Mar 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Healthkart
Quality Assurance Manager
Sun May 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jun 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Sun Pharma
Senior Executive
Tue Mar 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jul 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Intas Pharmaceuticals
Quality Assurance Supervisor
Thu Oct 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Mar 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Lupin
Quality Assurance Analyst
Tue Aug 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Oct 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time)
Glenmark Pharmaceuticals
Microbiologist
Mon May 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Aug 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)
Ind Swift
Microbiologist
Tue Jun 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon May 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)
Baxter International
Senior Quality Assurance Specialist
— Present