Padmavathi Rangisetty

FAQ About Padmavathi Rangisetty

• What is Padmavathi Rangisetty's address?

  Padmavathi Rangisetty is located at
  India

• What is Padmavathi Rangisetty's job title?

  Padmavathi Rangisetty is a
  An established, self-motivated & result-oriented regulatory professional with more than a one and half decade long broad & diversified experience in the International regulatory affairs and in regulatory compliance with the reputed pharmaceutical companies backed by a sound academic educational background. During my total experience of 15+ years, I have equipped myself with all functions during GDUFA era, which includes;  Leveraged skills in CMC documentation for preparing, amending and updating the Drug Master Files (DMFs) / CEP’s of APIs as per USFDA (Type-II & Type-V DMF’s), EDQM & Healthcare, Health Canada (Type-I CDMF’s) TGA, WHO (APIMF’s) and other RoW markets  In‐depth knowledge of ‘Quality management system’ as per current good manufacturing practices. Contribution in different quality assurance functions; participation in various global customer audits and health authorities (HA) audits like USFDA, EDQM, BfArM‐ Germany, ANSM‐ France, Korean FDA, Health Canada etc.  An enterprising leader with outstanding decision‐making & problem-solving skills and competencies in leading personnel towards accomplishment of company goals  Identification, screening and assessment of Genotoxic, Carcinogenic, ‘High-potency mutagenic carcinogens’ (“cohort of concern”) and other potential impurities involved in API’s & SM and setting suitable limits  Expertise on handling global Regulatory audits for sterile and non-sterile API facilities  Expertise on ‘Sterility Assurance’ and ‘Aseptic process’ of Sterile API’s/Dosage forms.  Writing investigation reports with respect to API quality Management systems, ‘Sterility Assurance’ and ‘Microbiology’ related aspects  Writing scientific responses on deficiencies raised by the global regulatory authorities especially US FDA under GDUFA, EDQM, EU National competent authorities, Health Canada (TPD) and customers as per current regulatory requirements.  Identify the critical issues related to Regulatory & cGMP as a member of the Regulatory Affairs and contributing to defining the regulatory strategy. Msn Laboratories

• What industry does Padmavathi Rangisetty currently work in?

  Padmavathi Rangisetty currently works in the
  Msn Laboratories

• What is Padmavathi Rangisetty's area of expertise?

  Padmavathi Rangisetty specializes in
  An established, self-motivated & result-oriented regulatory professional with more than a one and half decade long broad & diversified experience in the International regulatory affairs and in regulatory compliance with the reputed pharmaceutical companies backed by a sound academic educational background. During my total experience of 15+ years, I have equipped myself with all functions during GDUFA era, which includes;  Leveraged skills in CMC documentation for preparing, amending and updating the Drug Master Files (DMFs) / CEP’s of APIs as per USFDA (Type-II & Type-V DMF’s), EDQM & Healthcare, Health Canada (Type-I CDMF’s) TGA, WHO (APIMF’s) and other RoW markets  In‐depth knowledge of ‘Quality management system’ as per current good manufacturing practices. Contribution in different quality assurance functions; participation in various global customer audits and health authorities (HA) audits like USFDA, EDQM, BfArM‐ Germany, ANSM‐ France, Korean FDA, Health Canada etc.  An enterprising leader with outstanding decision‐making & problem-solving skills and competencies in leading personnel towards accomplishment of company goals  Identification, screening and assessment of Genotoxic, Carcinogenic, ‘High-potency mutagenic carcinogens’ (“cohort of concern”) and other potential impurities involved in API’s & SM and setting suitable limits  Expertise on handling global Regulatory audits for sterile and non-sterile API facilities  Expertise on ‘Sterility Assurance’ and ‘Aseptic process’ of Sterile API’s/Dosage forms.  Writing investigation reports with respect to API quality Management systems, ‘Sterility Assurance’ and ‘Microbiology’ related aspects  Writing scientific responses on deficiencies raised by the global regulatory authorities especially US FDA under GDUFA, EDQM, EU National competent authorities, Health Canada (TPD) and customers as per current regulatory requirements.  Identify the critical issues related to Regulatory & cGMP as a member of the Regulatory Affairs and contributing to defining the regulatory strategy.

• Which languages does Padmavathi Rangisetty speak? 

  Padmavathi Rangisetty speaks the following languages:
  No languages available.

• Which industries has Padmavathi Rangisetty previously worked in?   

  Padmavathi Rangisetty has prior experience in the following industries:
  Msn Laboratories

• What is Padmavathi Rangisetty’s work experience?  

  Padmavathi Rangisetty has the following professional experience:
  Msn Laboratories , Msn Laboratories .

• How can I find Padmavathi Rangisetty on LinkedIn?  

  You can view Padmavathi Rangisetty’s
  LinkedIn profile at LinkedIn URL.

• What are Padmavathi Rangisetty’s work email addresses?  

  Padmavathi Rangisetty’s work email addresses are
  [email protected] .

• What company does Padmavathi Rangisetty work for?  

  Padmavathi Rangisetty works at
  Msn Laboratories