Shefali Patel Email & Phone Number | Experienced specialist in Biotechnology /Pharmaceutical Industry: • Effective collaborator with Quality Control/Quality assurance, Manufacturing, SQM, Process Development and Research. • Managing stability program for commercial products • Strong cGMP skills in Quality Data Analyses (Product release/stability trending, Analytical development) and documentation (authoring and reviewing SOPs, Technical Registration Documents (TRD), Technical assessment reports, Stability Protocol/ Reports; Drug Specification/CofA, OOS/OOT investigation, Root cause analysis/non-conformance; CAPA and Change Control, Risk assessment) • Conducting and supporting Compliance Inspections and Audits/Quality Matrices • Project management with CTL/CRO/CMO for Analytical Method Development, Assay Qualification / Validation, Technology Transfer and Drug stability program • Hands-on / trouble shooting expertise in Assay Development for Microbiology/Immunology, Virology, and Drug Stability • Strong problem solving and communication skills with effective verbal and writing ability • Highly motivated specialist, quick and eager learner, skilled team member as well as independent contributor with supervisory experience.

Shefali Patel

Experienced specialist in Biotechnology /Pharmaceutical Industry: • Effective collaborator with Qual...
San Francisco Bay Area, San Francisco Bay Area, United States

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Shefali Patel’s Email shefali.patel@jnj.com

Shefali Patel’s Phone Numbers

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Shefali Patel’s Location San Francisco Bay Area, San Francisco Bay Area, United States

Shefali Patel’s Current Industry Bayer Healthcare

Shefali Patel’s Prior Industry Gilead Sciences | Hospira | Janssen Alzheimer Immunotherapy | Affymax | Medimmune Vaccines

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Work Experience

Bayer Healthcare

Sr. Specialist - QC Operations

2014-12-01 00:00:00 - Present

Gilead Sciences

QC/QA Consultant

2014-01-01 00:00:00 - 2014-08-01 00:00:00

Hospira

QC Investigator - Consultant

2013-06-01 00:00:00 - 2013-12-01 00:00:00

Janssen Alzheimer Immunotherapy

Sr. QC/AD/Analytical QA - Contractor

2011-04-01 00:00:00 - 2012-10-01 00:00:00

Affymax

Scientist

2008-01-01 00:00:00 - 2010-01-01 00:00:00

Medimmune Vaccines

Associate Scientist II - Vaccines Analytical Sciences

2002-01-01 00:00:00 - 2008-01-01 00:00:00

Skills

No Skills Available

Languages

No Languages Available

FAQ About Shefali Patel

Shefali Patel is located at
San Francisco Bay Area, San Francisco Bay Area, United States

Shefali Patel is a Experienced specialist in Biotechnology /Pharmaceutical Industry: • Effective collaborator with Quality Control/Quality assurance, Manufacturing, SQM, Process Development and Research. • Managing stability program for commercial products • Strong cGMP skills in Quality Data Analyses (Product release/stability trending, Analytical development) and documentation (authoring and reviewing SOPs, Technical Registration Documents (TRD), Technical assessment reports, Stability Protocol/ Reports; Drug Specification/CofA, OOS/OOT investigation, Root cause analysis/non-conformance; CAPA and Change Control, Risk assessment) • Conducting and supporting Compliance Inspections and Audits/Quality Matrices • Project management with CTL/CRO/CMO for Analytical Method Development, Assay Qualification / Validation, Technology Transfer and Drug stability program • Hands-on / trouble shooting expertise in Assay Development for Microbiology/Immunology, Virology, and Drug Stability • Strong problem solving and communication skills with effective verbal and writing ability • Highly motivated specialist, quick and eager learner, skilled team member as well as independent contributor with supervisory experience.

Shefali Patel currently works in the Bayer Healthcare |

No Languages Available

Shefali Patel has prior
experience in the following industries:
Gilead Sciences | Hospira | Janssen Alzheimer Immunotherapy | Affymax | Medimmune Vaccines

Shefali Patel has the following professional experience:
Bayer Healthcare | Gilead Sciences | Hospira | Janssen Alzheimer Immunotherapy | Affymax | Medimmune Vaccines