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Job Details

QA Validation Specialist

Equipment/Technology Specialist

Equipment and Facilities Specialist


Millburn, New Jersey, United States

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. <br>We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!<br>Imagine what you could do here at Novartis! <br><br>Your responsibilities include, but are not limited to:<br><br>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.<br>- 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<br>- Support establishment, review and approve maintenance plans and calibration strategy, and execution in collaboration with site Engineering function.<br>- Review of deviations / non-conformances and lead the strategic discussion for investigations with respect to operations or validation related matters<br>- 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<br>- 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.<br>- Perform final review of test data/reports to ensure conformance to the established specifications and standard operating procedures. Act as Responsible Person for the final disposition of products.<br>- Ensures supplier qualification activities are performed, including audits execution and Quality Agreements preparations.<br>- Contribute to the generation of the Annual Product Reviews.<br>- Primary SME for the GMP regulatory inspections, specifically for qualification and validation matters<br>- Ensure the coaching and training of the quality team and other associates within the Production and QC in qualification and validation field<br><br>Note: Monday – Friday days<br><br>