Process Validation Scientist
CurrentProcess Validation/ CPV/ Technical Transfer/ Process Optimization
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@frontidabiopharm.com
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Samir Patel is listed as Process Validation Scientist at Adare Pharma Solutions, a with 321 employees, based in Greater Philadelphia, United States. AeroLeads shows a work email signal at frontidabiopharm.com and a matched LinkedIn profile for Samir Patel.
Samir Patel previously worked as Validation Tech III at Url Pharma, Inc./ Sun Pharma Usa and Lead Tech, Blending & Granulation Department at Url Pharma, Inc.. Samir Patel holds Associate Of Arts (A.A.), Business Administration And Management, General from Bucks County Community College.
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- Process Validation/ CPV/ Qualification of commercial drug products (Protocol driven, extensive validation testing)- MFR mark-ups, detailed changes, change controls, SOPs new/biennial reviews, Temporary Process changes (TPC), investigations, Protocols, Reports, Addendum/Addendum via MasterControl and/or PharmaReady (EQMS)- Stability of the drug product (bulk hold time studies, hopper stratification studies, Post approval stability protocols, Process Validation Stability)- Statistical analysis of the process using JMP statistical software (statistical summary, process capabilities, overlay plot etc.)- Observation of critical parameters, sampling and troubleshooting in Manufacturing departments during PV projects. - Analysis of In-process manufacturing data, analytical data, ASTM testing- Preparation of PV/ CPV/ Qualification reports- Annual Product Review (APRs) support to compliance for filing purposes. - Process optimization studies (granulation, blending, compression, coating and encapsulation improvements)- Tech. Transfers (Alternate API, Alternate site, Scale-ups/downs, Equipment/Process SUPAC changes)-CTM (Clinical Trail Material) support to R&D for registration/submission work for FDA filing
Listed skills include Validation, Gmp, Fda, Pharmaceutical Industry, and 20 others.
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Philadelphia, Pennsylvania
Process Validation/ CPV/ Technical Transfer/ Process Optimization
Validations/Scale-ups/Technical Services/Process Optimization/Alternate site/Alternate API
Other employees you can reach at adarepharmasolutions.com. View company contacts for 321 employees →
Marco Maini
Colleague at Adare Pharma SolutionsMilan, Lombardy, Italy
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Gagnon Charles-David
Colleague at Adare Pharma SolutionsMcmasterville, Quebec, Canada
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Camilla Turturo
Colleague at Adare Pharma SolutionsGreater Milan Metropolitan Area, Italy
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Giovanni Avallone
Colleague at Adare Pharma SolutionsMonza, Lombardy, Italy
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Laura Contu
Colleague at Adare Pharma SolutionsGorgonzola, Lombardy, Italy
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Haneen Jasim
Colleague at Adare Pharma SolutionsCincinnati Metropolitan Area, United States
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Mitiul Patel
Colleague at Adare Pharma SolutionsHightstown, New Jersey, United States
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Paula Eichman
Colleague at Adare Pharma SolutionsDayton Metropolitan Area, United States
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James Gilbert
Colleague at Adare Pharma SolutionsGermantown, Ohio, United States
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Martina Fantasia
Colleague at Adare Pharma SolutionsMilan, Lombardy, Italy
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Quick answers generated from the profile data available on this page.
Samir Patel works for Adare Pharma Solutions.
Samir Patel is listed as Process Validation Scientist at Adare Pharma Solutions.
AeroLeads has found 1 work email signal at @frontidabiopharm.com for Samir Patel at Adare Pharma Solutions.
Samir Patel is based in Greater Philadelphia, United States while working with Adare Pharma Solutions.
Samir Patel has worked for Adare Pharma Solutions, Url Pharma, Inc./ Sun Pharma Usa, and Url Pharma, Inc..
Samir Patel's colleagues at Adare Pharma Solutions include Marco Maini, Gagnon Charles-David, Camilla Turturo, Giovanni Avallone, and Laura Contu.
You can use AeroLeads to view verified contact signals for Samir Patel at Adare Pharma Solutions, including work email, phone, and LinkedIn data when available.
Samir Patel holds Associate Of Arts (A.A.), Business Administration And Management, General from Bucks County Community College.
Samir Patel is listed with skills including Validation, Gmp, Fda, Pharmaceutical Industry, Sop, Change Control, 21 Cfr Part 11, and Process Improvement.
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