Suresh Kumar Ch Email and Phone Number
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Over 18+ years of enriched experience in Regulatory Affairs & QA both Sterile and Non-sterile domain. Well-versed with filings of quality DMFs' in US, EU, Canada, WHO, Australia and CEPs' with EDQM & HealthCare. Sound knowledge of Analytical, Quality Assurance, Aseptic Process and Technology Transfer activities. Expertise in drafting clear responses to deficiencies raised by Regulators and Global customers , Familiar with Life cycle management of DMFs' & CEPs'., Good understanding and knowledge of R&D related activities especially wrt Process development & control strategies and Cross-functional training.Well-versed with Sterility Assurance (Aseptic Process) of Injectable API and formulation facilities.Possess project management skills, People management skills, Good understanding of regulatory requirements, cGMP & Compliance for US & EU and other Regulated markets. Established team building and leadership skills. Good in problem solving skills.Had a shop-floor experience in Quality Control, Microbiology and Quality Assurance. Have lead teams that have submitted +120 US DMFs' and + 65 EU DMFs' (NA/DCP/MRP) and + over 50 Canadian DMFs', 25 CEPs' and etc. in overall experience.
Amneal Pharmaceuticals
View- Website:
- amneal.com
- Employees:
- 3128
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Deputy General Manager-Regulatory AffairsAmneal Pharmaceuticals Jan 2020 - PresentAhmedabadResponsible and accountable for DMF filings
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Asst.General Manager-Regulatory Affairs (Api'S)Amneal Pharmaceuticals Jan 2017 - Dec 2019Vishakhapatnam Area, India
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Senior Manager-Regulatory AffairsAmneal Pharmaceuticals Apr 2014 - Dec 2016Responsible for DMF's (API)
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Manager-Regulatory AffairsAmneal Pharmaceuticals Jun 2013 - Mar 2014Vishakhapatnam Area, IndiaTaking care of Regulatory functions at 2 API manufacturing sites and R&D facility
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Deputy Manager-Regulatory AffairsBiocon Nov 2010 - May 2013BangaloreResponsible for DMF/ CEP's filing for US, Canada, Europe, RoW and etc. Regulatory support to R&D for new molecules (under pipeline) and already established moleculesWriting clear responses (Debate/Explanation) to Regulatory authorities and key customersVendor evaluation for KSM in regulatory prospective.Proficient in Genotoxic assessmentRegulatory Audit compliance and etc.. -
Asst. Manager-Regulatory Affairs & CqaAurobindo Pharma Feb 2007 - Oct 2010Hyderabad Area, India• Involvement in CMC documentation for preparing, amending and updating the Drug Master Files (DMFs) / CEP’s/ Common Technical Documents (CTDs) of APIs as per USFDA (Type-II & Type-V DMF’s), EDQM & Health Care, Health Canada (Type-I CDMF’s) TGA, WHO (APIMF’s) and other regulatory authorities requirements.• Preparation of responses on Regulatory authority’s queries / deficiencies as per current regulatory requirements.• Expertise on “Sterilization and Aseptic Process” of Sterile API’s/ Injectable formulations.. Regulatory support for ANDA/ MAA team w.r.t Sterility Assurance and Aseptic process activities
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Management Staff-Quality AssuranceCipla Feb 2006 - Feb 2007Pune Area, IndiaWorked as a Validation team head in Quality Assurance. Familiar with all key validation i.e. Water system, Analytical Method validations, Cleaning and HVAC System validations. Expertise on evaluation of Change Controls, Deviations and OOS. Established Quality Management system. Actively participated in Regulatory Audits i.e.US-FDA, WHO and other customer's domestic & overseas audits. -
Sr.Chemist / QcNeuland Laboratories Limited Jun 2003 - Feb 2006Hyderabad Area, India•Responsible for Quality Control related activities•Preparation of SOP’s, Specifications, CoA’s, Method of Analysis and Validation protocols•Microbiological Analysis of Water, Raw materials and Finished API •Evaluation of Clean rooms by Environmental Monitoring study•Familiar with Chromatography•Calibration of Quality Control related equipments
Suresh Kumar Ch Skills
Suresh Kumar Ch Education Details
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Chemistry, Botany & Zoology -
Biotechnology And Pharmaceutical Chemistry
Frequently Asked Questions about Suresh Kumar Ch
What company does Suresh Kumar Ch work for?
Suresh Kumar Ch works for Amneal Pharmaceuticals
What is Suresh Kumar Ch's role at the current company?
Suresh Kumar Ch's current role is Deputy General Manager-Regulatory Affairs at Amneal Pharmaceuticals.
What is Suresh Kumar Ch's email address?
Suresh Kumar Ch's email address is su****@****ail.com
What is Suresh Kumar Ch's direct phone number?
Suresh Kumar Ch's direct phone number is +173283*****
What schools did Suresh Kumar Ch attend?
Suresh Kumar Ch attended Andhra University, Bharathidasan University, Gandhi Institute Of Technology & Management (Gitam) University, Visakhapatnam.
What are some of Suresh Kumar Ch's interests?
Suresh Kumar Ch has interest in Delivering Seminor's Related To C Gmp.
What skills is Suresh Kumar Ch known for?
Suresh Kumar Ch has skills like Validation, Fda, Regulatory Requirements, V&v, Change Control, Aseptic Processing, Regulatory Submissions, Cleaning Validation.
Who are Suresh Kumar Ch's colleagues?
Suresh Kumar Ch's colleagues are Bhavik Patel, John Is, Ayesha ., Krishna Gahlot, Anil Dwivedi, Rutvik Patel, Rushikesh Patil.
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Suresh kumar Ch
Data Analyst || Secondary Researcher || Data Sourcing & Insights || Company Profiling || Cross Industry || Bloomberg || D&B Hoovers || Mergers & Acquisitions || Private Equity || Venture Capital || Market Researcher ||Hyderabad -
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Suresh Kumar Ch
Associate Automation Architect || Automation Test Engineer || Ranorex || Selenium || Uft || Katalon || CypressChennai -
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