One Vector will serve biotech and pharma clients by providing IT Advisory, Compliance, Cloud Optimization, and Data Sciences, by leveraging AI & ML tools that use Big Data to solve complex problems.

Syner-G Pharma is a Boston based consulting firm specializing in providing customized global Chemistry Manufacturing Controls Regulatory Affairs, and Quality Assurance services for Pharmaceutical, Biotech and Medical Device companies.

Heading the IT Compliance, Auditing and Validation practice at Cambridge IT Compliance . Responsible for day to day operations, including business development, managing client expectations, recruiting, training and placing resources. Cambridge IT provides Compliance, Auditing, Validation services for pharmaceutical and biotech companies. With deep domain expertise in U.S. FDA electronic data integrity regulations, our team provides custom GxP IT services.Cambridge IT is your one stop GxP IT solution partner. For more information visit www.CambridgeITLLC.com

Co-lead QA/Validation effort for facilities and equipment and manage project timelines and project plan.

Lead the effort to implement Document Management Systems and QA/IT- Policies/SOPs.

As a Quality Lead, I work independently on multiple complex projects and take a lead role in the design and execution of new projects and systems. Duties include assisting with project planning and provide input on design and methodology development. Adapt to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements. Personal contribution to Quality department:  Brand ambassador for Quality  Intrapreneurial approach to processes and procedures Risk based approach to validation Taking ownership and accountability for quality  Influence customers by building a positive relationship for Quality Strategic contributor who can quickly de-escalate and build allies for Quality  Make independent decisions, identify problems and solve them with minimal supervision  De-escalates problem, and handles difficult situations while managing customer expectations SME on Computer System validation, change management, CAPA, and Gap analysis Never hesitant to step in and help team membersList of systems (2008-2011): eDMS system critical for NDA submissions Patient Safety System Document management system HCV Sequence Database Electronic common technical document (eCTD) tools, critical for NDA submissions Change management system SAS  Jreview Labware LIMS Electronic Lab Notebook (ELN)  Stability LIMS Standalone instruments  SCADA and PLC systemsOther contributions to Quality department: Mentor and coached interns  Led Communication team for Quality Systems group

As quality assurance professional, my responsibility is to ensure that Vertex’s science groups have the most robust, reliable and compliant systems that supports Incivek™ and other drug products. My responsibility includes taking ownership and accountability of compliance and compliance related queries for our partners. Groups served include Patient Safety, Information Systems, Regulatory, Medicinal Chemistry, Analytical Development, Release Stability, Quality Control, Formulation and Process Automation (Facilities).

My Piece of Chennai, a start-up volunteer organization helping address civic needs of Chennai, India.

Mentor and teach College algebra to non-traditional students.

Build from scratch a small consulting firm that provided highly skilled Information Systems engineers who were proficient in implementing SAP systems for fortune 500 companies.

Manage validation of multi-site Manufacturing Informatics Networked Information Database (MIND) for Enbrel and Prevnar at Andover, MA site.

Consent Decree Project, identifying gaps on existing lab and manufacturing systems and resolving them by retrospective validation at Kenilworth Campus in NJ.