Experience

Aura Pharma

• Brazil
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Executive

  • Jul 2021 - Present

  Preparation, Review of dossiers Recheck prepared dossier by others Preparation, Review of dossiers Recheck prepared dossier by others



Ajanta Pharma Ltd

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr.Officer Drug Regulatory Affairs-ROW

  • Oct 2015 - May 2020

  • Understanding of ICH, USFDA, WHO guidelines of regulatory. • Review of technical documents i.e. API row data, BMR, PVP/PVR. • Knowledge of reviewing analytical validation, DMF. • Sound knowledge of ICH guidelines. • handled the filing of semi-regulated market & post-approval changes. • To prepare IOC for COPP/FSC and legal applications. • To update and follow-ups for Minutes of the meeting of Regulatory Affairs. • Updation of MOM • Completion of SOP and follow up. • SAP handling. • Management, coordinate different department for the completion of work within the time limit Show less



MISTAIR HEALTH AND HYGIENE PRIVATE LIMITED

• India
• Food and Beverage Manufacturing
• 1 - 100 Employee

• Microbiologist in Quality Control Dept

  • Oct 2013 - Oct 2015

  • Responsible for the preparation of SOPS, department related all documents preparation. • Responsible for testing of All Medicines, Raw Materials, Finish Product. • Responsible for the validation of using instruments such as Microscope, Autoclave, Incubators, Micropipette calibration, glassware Calibration. • Responsible for the environmental monitoring of manufacturing with bottle washing, manufacturing core and liquid filling area, sampling area, dispensing area, external manufacturing area, external powder area, veterinary area, cap checking the area, sugar dispensing area, departments. • Responsible for validation of routine and non- routine period such as AHU validation, worst case product cleaning validation, drain volume validation, disinfectant efficacy study, compressed air validation, and Well known with the documentation required for Quality Control Department. Show less



Elder Health Care Limited ( Factory)

• India
• Motor Vehicle Manufacturing

• Head of the department of Microbiology in Quality Control Dept.

  • Jul 2013 - Oct 2013

  • Responsible for the preparation of SOP • Responsible for testing of All Medicines, Raw Materials, Finish Product. • Responsible for the validation of using instruments such as a microscope, UV spectrophotometer, optical rotation, refractive index, incubator, laminar airflow. • Responsible for the environmental monitoring of specified departments. • Well known with the documentation required for Quality Control Department • Responsible for the preparation of SOP • Responsible for testing of All Medicines, Raw Materials, Finish Product. • Responsible for the validation of using instruments such as a microscope, UV spectrophotometer, optical rotation, refractive index, incubator, laminar airflow. • Responsible for the environmental monitoring of specified departments. • Well known with the documentation required for Quality Control Department