Through analytical testing, determinations must be made whether analytical methods are suitable to use for quality release testing as per FDA/ICH requirements. Also responsible for maintaining data integrity via notebook review/approval, audit trail review/approval, performing software backups, creating and executing validation/forced degradation protocols, authoring and reviewing validation protocols and reports, ensuring system/user access is maintained and GDP is followed. Must have excellent analytical chemistry skills, strong knowledge of compliance and cGMP, communication skills, excellent organizational skills, time management skills, be able to interact with senior management and formulation chemists. Extensive knowledge of Analytical Instrumentation, Chemistry, Pharmaceutical regulations and Pharmaceutical Industry in general, especially focused on analytical validation. Should you wish to apply for this position or any other position with the Company and you believe you require assistance to complete an application or participate in an interview, please contact USApplicantAccommodations@Estee.com.
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