
Rachana Patel
Experienced Quality Assurance and Regulatory Compliance professional with 4+ years of in GMP environments. I hold a Master... | Haverhill, Massachusetts, United States
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Rachana Patel’s Emails rp****@bl****.com
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Rachana Patel’s Location Haverhill, Massachusetts, United States
Rachana Patel’s Expertise Experienced Quality Assurance and Regulatory Compliance professional with 4+ years of in GMP environments. I hold a Master of Science in Project Management with a concentration in Regulatory Affairs for drugs, biologics and medical devices and completed M.Tech in Biotechnology. My background and skills has equipped me with the knowledge to manage complex quality systems and ensure compliance with regulatory standards in Biopharma and Medical Device industries. Skills: Regulatory Skills : Quality Management Systems Events and Actions, Business Administrator for Veeva Systems, Employee Training program, Vendor Record Management, Risk Management, Product Complaint Intake and processing, GMP QA Operations. Medical device Skills : UL (safety), CE, EMC (FCC), RF (FCC), IEC60601(medical), IEC 61010 (industrial), IEC 61326, IEC 62304 (software), Software testing etc and others. Project Management skills : MS Project, JIRA, MS Visio, Minitab, MS Office Suite etc. - Proven experience in a regulated healthcare industry. - Experience in a fast paced, complex operation. - Ability to collaborate and communicate concepts in a way that is easily understood. - Self-directed with flexibility to work independently and on teams. - Time and project management skills. - Strong problem solving, root cause analysis and analytical experience. - Knowledge of applicable FDA regulations and ISO-13485 standards.
Rachana Patel’s Current Industry Blueprint Medicines
Rachana
Patel’s Prior Industry
Serum Institute
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Innox
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Girl Scouts Of The Usa
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Tekscan
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Sanofi
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Akston Biosciences
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Blueprint Medicines
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Work Experience

Blueprint Medicines
Specialist, Quality System and Compliance
Fri Apr 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Akston Biosciences
Quality Assurance Associate III
Thu Apr 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Mar 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Sanofi
Compliance Specialist lll
Tue Dec 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Apr 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Tekscan
Regulatory Compliance Engineer
Fri Nov 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Oct 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Girl Scouts Of The Usa
Project Manager
Mon Apr 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jun 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Innox
Project Coordinator
Sat Sep 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Dec 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Serum Institute
R&D & Quality Control Specialist
Sun Jan 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Aug 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)