Babu Satram Email & Phone Number | Senior IT professional with extensive experience across diverse areas in Pharmaceutical, Clinical and Health Care industries. Satram is a result driven, focused technology savvy QA Project Manager with a consistent track record of delivering projects across multiple disciplines. Provides strategic leadership and direction for validation/QA activities specific to all GxP and Business Units. A highly skilled project-oriented individual with an extensive knowledge of Regulations and comprehensive understanding of QA and compliance procedures. Extensive experience in ICE/IGM methods, validations, project management, change management, configuration of safety systems, Clinical systems, Equipment Qualification, SDLC methodologies, Business Process Analysis and Quality Assurance. Extensive experience in FDA guidelines and GxP regulations implementations. Maintained consistency and standardized approaches to process validation across projects and global sites. Member of IGM body and actively participated in the guidance, governance and implementation of IGM policies across domains. Process validation expert and implemented several structured processes/programs to meet company expectations and requirements. Managed HP Quality center and provided Training to all teams. Mentored and trained cross functional teams of onsite and offshore resources in requirements, process validation programs, IGM guidelines, SOPs and GxP regulations. Hands on experience in writing SOPs and Validation Master plans. Known as an effective team player who goes above and beyond to meet and exceed goals.

Babu Satram

Senior IT professional with extensive experience across diverse areas in Pharmaceutical, Clinical an...
Norwalk, Connecticut, United States

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Babu Satram’s Email babu.satram@novartis.com

Babu Satram’s Phone Numbers +1 212-830-****

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Babu Satram’s Location Norwalk, Connecticut, United States

Babu Satram’s Current Industry Novartis Consumer Health

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Work Experience

Novartis Consumer Health

Senior Operational Quality Manager

2010-12-01 00:00:00 - Present

Cognizant Technology Solutions

Senior Manager

2008-07-01 00:00:00 - 2015-12-01 00:00:00

Medimmune

Manager

2008-06-01 00:00:00 - 2010-12-01 00:00:00

Fujifilm

Manager

2007-06-01 00:00:00 - 2008-05-01 00:00:00

Ge Health Care

Project Manager

2006-01-01 00:00:00 - 2007-01-01 00:00:00

Covance

Validation Lead/Team Lead

2006-01-01 00:00:00 - 2006-11-01 00:00:00

Daiichi Sankyo

Validation Lead

2005-01-01 00:00:00 - 2005-12-01 00:00:00

Prudue Pharma

Test Manager

2004-03-01 00:00:00 - 2004-12-01 00:00:00

Roche

Global Process QA Coordinator

2002-03-01 00:00:00 - 2004-02-01 00:00:00

Pfizer

Validation Lead

2000-03-01 00:00:00 - 2002-02-01 00:00:00

Skills

No Skills Available

Languages

No Languages Available

FAQ About Babu Satram

Babu Satram is located at
Norwalk, Connecticut, United States

Babu Satram is a Senior IT professional with extensive experience across diverse areas in Pharmaceutical, Clinical and Health Care industries. Satram is a result driven, focused technology savvy QA Project Manager with a consistent track record of delivering projects across multiple disciplines. Provides strategic leadership and direction for validation/QA activities specific to all GxP and Business Units. A highly skilled project-oriented individual with an extensive knowledge of Regulations and comprehensive understanding of QA and compliance procedures. Extensive experience in ICE/IGM methods, validations, project management, change management, configuration of safety systems, Clinical systems, Equipment Qualification, SDLC methodologies, Business Process Analysis and Quality Assurance. Extensive experience in FDA guidelines and GxP regulations implementations. Maintained consistency and standardized approaches to process validation across projects and global sites. Member of IGM body and actively participated in the guidance, governance and implementation of IGM policies across domains. Process validation expert and implemented several structured processes/programs to meet company expectations and requirements. Managed HP Quality center and provided Training to all teams. Mentored and trained cross functional teams of onsite and offshore resources in requirements, process validation programs, IGM guidelines, SOPs and GxP regulations. Hands on experience in writing SOPs and Validation Master plans. Known as an effective team player who goes above and beyond to meet and exceed goals.

Babu Satram currently works in the Novartis Consumer Health |

No Languages Available

Babu Satram has prior
experience in the following industries:
Cognizant Technology Solutions | Medimmune | Fujifilm | Ge Health Care | Covance | Daiichi Sankyo | Prudue Pharma | Roche | Pfizer

Babu Satram has the following professional experience:
Novartis Consumer Health | Cognizant Technology Solutions | Medimmune | Fujifilm | Ge Health Care | Covance | Daiichi Sankyo | Prudue Pharma | Roche | Pfizer