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| Assoc Director NE Open (J#45740) Title: Assoc Director Company: Novartis Salary: Open Job Description Manage the Site Analytical Services activities to ensure compliance of analytical methods and associated Quality systems with the requirements of the Novartis Quality Manual and all relevant regulatory and legislative requirements across the lifecycle of the OTC products. Support analytical activities at third parties, as appropriate. Establish and maintain Quality System for the Analytical Services group; ensure that Standard Operating Procedures are in place and that compliance with cGMP is maintained through ongoing training and internal audits. Ensure the implementation and on-going monitoring of Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs). Ensure that all new product launches and commercial BD&L projects are adequately supported through Analytical Services activities in line with Novartis Quality Manual requirements. Ensure that the Analytical Services group operates in a cost effective and efficient manner and maintain an innovative approach based on productivity improvement and implementation of best practice. ? Provide analytical competence and technology to the site so that all analytical methods are state-of-the-art and in compliance with regulatory expectations. ? Lead the analytical method transfer to and from the site (e.g. from R&D and 3rd parties; to site QC and 3rd parties) ? Ensure that analytical methods are adequately developed, validated and maintained ? Ensure that analytical equipment is adequately calibrated and qualified prior to use and continuously kept in a qualified state ? Develop and implement analytical method validation plans ? Ensure that the on-going stability program is adequately managed ? Evaluate new analytical technologies for their suitability for the site products and manage their implementation, as appropriate ? Ensure that adequate and timely support for investigations (e.g. deviations, complaints) and troubleshooting is provided, where needed in conjunction with nominated third parties and other involved Novartis functions to minimize impact on product availability and sales ? Ensure the adequate and timely qualification of contract laboratories using appropriate QA management tools to monitor and ensure third party lab compliance with the Novartis Quality Manual and applicable regulatory requirements on an ongoing basis e.g. QA Agreements, audits with appropriate follow up, risk assessments, Product Optimization action plans, performance indicators, follow up stability and product quality review. ? Ensure that the site has an adequate program to keep their reference standards qualified ? Actively manage the Analytical Services team and set up their development and objective targets ? Assist the local QA units with preparation, management and follow up of Health Authority inspections, as needed ? Review and monitor action plans for correction of audit observations related to the Analytical Labs and follow-up as appropriate. ? Support MTS for process validation activities and production site transfers ? Participate in BD&L, Marketing, Legal, GMS TPO and Regulatory Affairs team meetings on new commercial BD&L projects and new product launches. ? Utilize active thinking to generate creative solutions to complex technical problems ? Proactively manage interactions and commitments to HA and GQA inspection findings and site readiness More... | |||
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