Sumit Patel
• Eight years+ of Pharmaceutical experience in a pharmaceutical GMP environment. • Excellent working knowledge of Quality Systems and cGMP standards. • Hire... | Beverly, Massachusetts, United States
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Sumit Patel’s Emails su****@qu****.com
Sumit Patel’s Phone Numbers No phone number available.
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Sumit Patel’s Location Beverly, Massachusetts, United States
Sumit Patel’s Expertise • Eight years+ of Pharmaceutical experience in a pharmaceutical GMP environment. • Excellent working knowledge of Quality Systems and cGMP standards. • Hire and retain the staff, develop and monitor performance and development plans for the staff. • Advanced knowledge in GMP, GLP, GCP, FDA, DEA, ICH, and 21 CFR Parts 210 & 211 quality guidelines. • Performed SAP Quality Management system for releasing incoming material, label material, semi-finished material and finished material. • Strong work experience in CMC and QC department to maintain the quality, purity & efficacy of the product. Good analytical knowledge coupled with problem-solving skill. • Write qualification/validation protocols and execute protocols. Resolve protocol discrepancies and investigations. • Worked on testing of raw material, in-line process material and final product. • Validation & Regulation: Strong work experience and academic concentration on validation & regulation for pharmaceuticals, and knowledge of IQ, OQ, PQ and SOPs. • Independently lead/participate on GMP self-inspection compliance audits and identify GMP compliance gaps or risks. • Assist in discrepancy investigations and deviations. • Advanced experience with Microsoft Office and Excel.
Sumit Patel’s Current Industry Akston Biosciences
Sumit
Patel’s Prior Industry
Merck
|
Norwich Pharma Services
|
Quotient Sciences
|
Akston Biosciences
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Work Experience
Akston Biosciences
Quality Control Manager
Mon May 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Akston Biosciences
Quality Control Scientist Ii (Biopharmaceuticals)
Sun May 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon May 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Akston Biosciences
Quality Control Scientist (Biopharmaceutical)
Sat May 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun May 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Quotient Sciences
Group Lead
Fri Nov 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat May 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Quotient Sciences
Analytical Scientist Iii
Tue Nov 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Sep 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Norwich Pharma Services
Quality Control Chemist Ii
Mon Apr 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Nov 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Merck
Quality Standard Consolidation Specialist/ Regulatory Scientist
Sat Oct 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Apr 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)Skills
Languages
Sumit Patel Email Addresses
FAQ About Sumit Patel
-
Sumit Patel is located at
Beverly, Massachusetts, United States -
Sumit Patel is a
• Eight years+ of Pharmaceutical experience in a pharmaceutical GMP environment. • Excellent working knowledge of Quality Systems and cGMP standards. • Hire and retain the staff, develop and monitor performance and development plans for the staff. • Advanced knowledge in GMP, GLP, GCP, FDA, DEA, ICH, and 21 CFR Parts 210 & 211 quality guidelines. • Performed SAP Quality Management system for releasing incoming material, label material, semi-finished material and finished material. • Strong work experience in CMC and QC department to maintain the quality, purity & efficacy of the product. Good analytical knowledge coupled with problem-solving skill. • Write qualification/validation protocols and execute protocols. Resolve protocol discrepancies and investigations. • Worked on testing of raw material, in-line process material and final product. • Validation & Regulation: Strong work experience and academic concentration on validation & regulation for pharmaceuticals, and knowledge of IQ, OQ, PQ and SOPs. • Independently lead/participate on GMP self-inspection compliance audits and identify GMP compliance gaps or risks. • Assist in discrepancy investigations and deviations. • Advanced experience with Microsoft Office and Excel. Akston Biosciences -
Sumit Patel currently works in the
Akston Biosciences -
Sumit Patel specializes in
• Eight years+ of Pharmaceutical experience in a pharmaceutical GMP environment. • Excellent working knowledge of Quality Systems and cGMP standards. • Hire and retain the staff, develop and monitor performance and development plans for the staff. • Advanced knowledge in GMP, GLP, GCP, FDA, DEA, ICH, and 21 CFR Parts 210 & 211 quality guidelines. • Performed SAP Quality Management system for releasing incoming material, label material, semi-finished material and finished material. • Strong work experience in CMC and QC department to maintain the quality, purity & efficacy of the product. Good analytical knowledge coupled with problem-solving skill. • Write qualification/validation protocols and execute protocols. Resolve protocol discrepancies and investigations. • Worked on testing of raw material, in-line process material and final product. • Validation & Regulation: Strong work experience and academic concentration on validation & regulation for pharmaceuticals, and knowledge of IQ, OQ, PQ and SOPs. • Independently lead/participate on GMP self-inspection compliance audits and identify GMP compliance gaps or risks. • Assist in discrepancy investigations and deviations. • Advanced experience with Microsoft Office and Excel. -
Sumit Patel speaks the following languages:
No languages available. -
Sumit Patel has prior experience in the following industries:
Akston Biosciences , Akston Biosciences , Quotient Sciences , Quotient Sciences , Norwich Pharma Services , Merck -
Sumit Patel has the following professional experience:
Akston Biosciences , Akston Biosciences , Akston Biosciences , Quotient Sciences , Quotient Sciences , Norwich Pharma Services , Merck . -
You can view Sumit Patel’s
LinkedIn profile at LinkedIn URL. -
Sumit Patel’s work email addresses are
[email protected] . -
Sumit Patel works at
Akston Biosciences
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