Cmc Manager
Mar 2017 - Mar 2019
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Hagit Amar Email & Phone Number
CMC Analytical Project Manager at Neuroderm
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Role
CMC Analytical Project Manager at Neuroderm
Location
Israel, Israel, Israel
Who is Hagit Amar? Overview
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Quick answer
Hagit Amar is listed as CMC Analytical Project Manager at Neuroderm based in Israel, Israel, Israel. AeroLeads shows a matched LinkedIn profile for Hagit Amar.
Hagit Amar previously worked as CMC Manager at Neuroderm and Training Lead at Omrix Biopharmaceuticals. Hagit Amar holds Bachelor Of Science (B.Sc.), Biotechnology from Tel-Hai Aacademic College.
Profile bio
About Hagit Amar
• M.Sc. in Technology Management and B.Sc. in Biotechnology.• Deep knowledge of working within GMP/GLP and regulatory environment (including Data Integrity).• Extensive experience in QC-QA processes.• Working with global interfaces.• Implementation of Standard Operating Procedures (SOP).• Proven success in people development and team building.• Extensive experience with SQL*LIMS, Empower, Trackwise, Wisdom.Contact info: hagitamar@gmail.com
Listed skills include Gmp, Validation, Pharmaceutical Industry, Sop, and 7 others.
6 roles
Hagit Amar work experience
A career timeline built from the work history available for this profile.
Training Lead
Jun 2016 - Mar 2017
Section Manager Qc Lab
- Responsibility of finished product release within compliance to various markets: USA, EU, Israel, Japan and more.
- Responsibility of lab incidents and lab investigation (out of specification, alert limits, atypical results).
- Participation & leading of internal and external audits: FDA, MHRA, Israeli Ministry of Health, etc.
- Updating & Implementation of Standard Operating Procedures (SOP).
- Leading improvement teams based on OPEX methodology to improve operational processes within the lab and the site. (i.e. lean documentation, investigation cycle time, test reduction etc.)
- Working with global interfaces: production, supply chain, QA, RA and laboratories.
Feb 2012 - Aug 2015
Analytical Compliance Researcher
- Writing analytical methods and specifications or update existing documents, according to the requirements of health authorities, pharmacopeia’s updates, R&D and internal SOP.
- Exposures to early stages of analytical/operational problems arise from the relevant interfaces (lab, QA, RA).
- Adopting analytical methods based on laboratory’s capabilities and providing professional opinion for changes in analytical documents (method/specification).
- Supporting these documents through all stages: preparation, approval by QA/RA, implementation in lab.
Nov 2010 - Feb 2012
Team Leader, Stability Laboratory
- Responsibility for batches release accordance to the specification and within compliance to regulatory requirements.
- Review and approval of laboratory analysis.
- Direct manager of 6 analysts.
Feb 2008 - Nov 2010
Analyst
- Analysis of finished product stability batches (extensive experience with HPLC)
- Working according to protocols (including USP/EP)
- Document lab results within compliance to GMP.
Apr 2006 - 2008
2 education records
Hagit Amar education
Bachelor Of Science (B.Sc.), Biotechnology
Tel-Hai Aacademic College
Master Of Science (M.Sc.), Technology Management
H.I.T.
FAQ
Frequently asked questions about Hagit Amar
Quick answers generated from the profile data available on this page.
What is Hagit Amar's role at their current company?
Hagit Amar is listed as CMC Analytical Project Manager at Neuroderm.
Where is Hagit Amar based?
Hagit Amar is based in Israel, Israel, Israel.
What companies has Hagit Amar worked for?
Hagit Amar has worked for Neuroderm, Omrix Biopharmaceuticals, and Teva Pharmaceuticals.
How can I contact Hagit Amar?
You can use AeroLeads to view verified contact signals for Hagit Amar, including work email, phone, and LinkedIn data when available.
What schools did Hagit Amar attend?
Hagit Amar holds Bachelor Of Science (B.Sc.), Biotechnology from Tel-Hai Aacademic College.
What skills is Hagit Amar known for?
Hagit Amar is listed with skills including Gmp, Validation, Pharmaceutical Industry, Sop, Analytical Chemistry, Glp, Hplc, and Technology Transfer.
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