Experience

Sam Chun Dang Pharm. Co. Ltd

• 1 - 100 Employee

• Deputy General Manager of GMP Compliance

  • Jul 2019 - Present

  Responsible for cGMP compliance in sterile ophthalmic manufacturing and testing, execution of US ANDA/EU CTD documentation, and EUGMP/USFDA audit compliance responses. Responsible for risk analysis and assesments for elemental/nitrosomine impurities in drug products. Responsible for extractable/leachable studies. Support in regulatory filings. Responsible for cGMP compliance in sterile ophthalmic manufacturing and testing, execution of US ANDA/EU CTD documentation, and EUGMP/USFDA audit compliance responses. Responsible for risk analysis and assesments for elemental/nitrosomine impurities in drug products. Responsible for extractable/leachable studies. Support in regulatory filings.



Vimedimex Medi – Pharma JSC

• 1 - 100 Employee

• Deputy General Manager of Projects

  • Dec 2017 - May 2019

  Consultant for design and documentation of greenfield project for sterile and OSD products manufacturing and testing facility. Consultant for design and documentation of greenfield project for sterile and OSD products manufacturing and testing facility.



Bharat Serums and Vaccines Limited

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Deputy General Manager of Projects

  • Dec 2017 - Mar 2019

  Consultant for Production, Validation & Engineering activities in sterile injectable line for successful EUGMP inspection. Consultant for Production, Validation & Engineering activities in sterile injectable line for successful EUGMP inspection.



Bruck Pharma Pvt. Ltd

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Manager of Quality Assurance

  • Apr 2015 - Nov 2017

  Head of quality assurance department, design, documentation, commissioning, and validation of Green Field Project for Sterile/non-sterile oncology products manufacturing and testing facility. Head of quality assurance department, design, documentation, commissioning, and validation of Green Field Project for Sterile/non-sterile oncology products manufacturing and testing facility.



Sam Chun Dang Pharm. Co. Ltd

• 1 - 100 Employee

• Manger of Validation

  • Feb 2013 - Mar 2015

  GMP consultant for validation activities in the sterile ophthalmic facility and successful MHRA inspection. GMP consultant for validation activities in the sterile ophthalmic facility and successful MHRA inspection.



Hospira

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Executive of Validation

  • Sep 2011 - Jan 2013

  Execution of commissioning, qualification, and validation activities in a sterile greenfield project (USFDA approved facility). Execution of commissioning, qualification, and validation activities in a sterile greenfield project (USFDA approved facility).



Mylan

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Assistant Manager of Quality Assurance

  • Sep 2008 - Sep 2011

  Incharge of quality assurance and validation activities in a sterile oncology greenfield project. Incharge of quality assurance and validation activities in a sterile oncology greenfield project.



Venus Remedies Limited

• India
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Senior Executive of Validation

  • Sep 2006 - Sep 2008

  Documentation, qualification, and validation activities in sterile oncology greenfield project (EUGMP approved facility). Documentation, qualification, and validation activities in sterile oncology greenfield project (EUGMP approved facility).



Gland Pharma Limited

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Chemist of Quality Assurance

  • Feb 2005 - Sep 2006

  In-process quality assurance activities in production and packaging operations of the sterile injectable facility (USFDA approved facility). In-process quality assurance activities in production and packaging operations of the sterile injectable facility (USFDA approved facility).