IN050 Ferring Laboratories Pvt. Ltd.

<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN" "http://www.w3.org/TR/REC-html40/loose.dtd"><html><body><h2> Job Description:</h2>The Director GQA Solid & Packaging Manufacturing Quality is primarily responsible for maintaining the license to operate at all Ferring Solids and Packaging manufacturing sites (FSMP, FCT, FLAS, FAR, FMX, FTPL and Synthese.Therefore, this role is key for Ferring in order to ensure “Delivery of high-quality products on time and in full” as well as “Customer focused innovation” as included in Group BSC.The Firector GQA Solid & Packaging Manufacturing Quality:<ul><li>Is a key position having key quality responsibility of Solid and Packaging manufacturing quality topics</li><li>Is a member of the GQA leadership team</li><li>Provide leadership to quality staffs based in FSMP, FCT, FLAS, FAR, FMX, FTPL, FLPL and Syntese</li><li>Provide leadership to more than 120 quality staff based in the associated manufacturing sites</li></ul>Main Accountabilities (duties, responsibilities) Compliance<ul><li>Lead quality oversight and carry out quality initiatives at associated Ferring manufacturing Sites</li><li>Translate the QA strategy into tangible, site specific quality plans in corporation with  Tech Ops and local organizations</li><li>Ensure site inspection readiness prior to inspections by health authorities </li><li>Provide strategic operational support to the Global Tech Ops organization   </li><li>Lead implementation of Inspection Review Board actions</li><li>Manage trouble shooting for critical deviations and follow up on corrective actions</li><li>Participate in the decision-making process of recalls</li><li>Lead the setting of TAs between HQ and associated manufacturing</li><li></li><li>Organize, drive and monitor execution of strategic quality initiatives across sites</li></ul> GQA Strategy<ul><li>Implement strategic quality objectives aligned with Tech Ops</li><li>Lead the implementation of the GQA strategy at the associated Manufacturing Sites</li></ul> Quality Systems<ul><li>Develop / improve CSOPs</li><li>Ensure that GMP requirements and  CSOPs are implemented and respected all over  the associated manufacturing sites</li><li>Perform GMP management training</li></ul> Performance Management<ul><li>Lead the implementation of the Quality KPI system and lead monitoring of improvement initiative at  associated manufacturing sites</li><li>Assess the quality risk in the area of responsibility and  implement risk mitigation actions</li></ul> People Management<ul><li>Manage the site quality unit for the associated Manufacturing sites</li><li>Establish objectives and  budget throughout the process for each site</li><li>Lead and motivate the sites QA teams in the achievement of their objectives</li><li>Decide  with site manager on recruitment of Quality manager or QA/QC positions on associated manufacturing sites</li></ul> Projects<ul><li>Carry out and lead quality harmonisation and alignment across the associated manufacturing sites</li><li>Work with R&D and Product Supply to provide a GQA input into technical transfer of projects in and out of manufacturing sites</li><li>Provide support and technical expertise to Tech Ops projects</li><li>Provide support and technical expertise to the Lean transformation</li></ul> Interface Management<ul><li>Drive the QRB process for associated sites and areas</li><li>Provide support and technical expertise to Development and OPS Projects</li><li>Prepare monthly report for the associated sites</li></ul> Required Education/Qualifications/Skills :<ul><li>Doctorate or academic degree in natural or applied sciences (Pharmacy, Chemistry, Engineering, Biotechnology)</li><li>Strong Knowledge of Business Regulations (EU, FDA and others)</li><li>Minimum of 15 years work experience in quality assurance and / or quality control in the pharmaceutical industry with both local and International working experience</li><li>Minimum of 5 years experience  in problem solving and process improvement</li><li>Fluent in English (written and verbal communication)</li><li>Excellent interpersonal and communication skills</li><li>Strong business mindset with demonstrated ability of conceptual and strategic thinking</li><li>Good project management skills</li></ul><h2> Location:</h2>Ferring India Laboratories</body></html>

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