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Form of workAt Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Quality Engineering professionals to help us reach our ambitious quality and validation goals.
The QA Validation Specialist will be responsible for management of the GMP Quality Assurance oversight of Qualification, Validation, in relation to Facility Equipment, Computerized Systems, Laboratory systems in order to meet our regulatory requirements in Millburn, NJ.
Key Responsibilities:
Represents site QA Validation SPOC (Single Point of Contact) for Facility Equipment and systems, Computerized Systems, Laboratory systems and participate on SOP authoring/review and implementation to site. Approves Validation strategy and plans for the site.
Act as SME (Subject Matter Experts) to develop validation and qualification procedures, train and guide site personnel in validation area including guidance on audit preparations or leading investigations whenever required.
Support establishment, review and approve maintenance plans and calibration strategy, and execution in collaboration with site Engineering function.
Review of deviations / non-conformances and lead the strategic discussion for investigations with respect to operations or validation related matters.
Review/approve investigation of operations in manufacturing/laboratory or other related operations. Oversee resolution of quality events, monitor that recurrent events are properly escalated and resolved. Ensure root cause is determined, evaluate impact on product quality, disposition and corrective actions.
Review and approve changes related to facility, computerized systems, laboratory or products. Ensure proper assessment with respect to Qualification and Validation is conducted. Performs QA oversight for Validation and Qualifications activities for Manufacturing, QC studies.
Contribute to the generation of the Annual Product Reviews.
Serve as SME for the GMP regulatory inspections, specifically for qualification and validation matters.
Ensure the coaching and training of the quality team and other associates within the Production and QC in qualification and validation field.
