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Quality Assurance Engineer(CMC)

Company: Accede Solutions Inc
Location: Newark
Posted on: November 18, 2020

Job Description:

Quality Assurance Engineer 6 months Required Experience and Skills: 3 years’ experience working within quality, regulatory and/or within pharmaceutical environment preferably in vaccines or biologic experience, is required’ Authoring and reviewing of CMC components for various submissions (e.g., post-approval changes, US annual reports, new license applications, renewals, commitments, response to questions) within pre-defined schedules in accordance with RA procedures, tools and templates and coordinating the final submissions, if required Candidate to be familiar with the main regulatory agency standards (US FDA, Europe and Canada) Assessing change control pre-requests and requests for Canada, US and Europe and preparing the global regulatory strategy Completing data entry for various activities in the regulatory system (i.e., Veeva Vault) Supporting various internal request (e.g., Quality deviations and assessments, data checking, license information, lot release questions, etc.) Ability to work in a group setting and independently; good teamwork skills Strong interpersonal and communication skills, both verbal and written

Keywords: Accede Solutions Inc, Newark , Quality Assurance Engineer(CMC), Other , Newark, New Jersey

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