David Adanny

Experience

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  QSF – Quality Safety Food

  Sept 2009 - Jan 2010

  Consultant and Chief Trainer

  Team leader of the Training Dept. offering consultancy and professional accreditation courses.• Provide ISO and HACCP compliance consultancy services to food manufacturing plants.• Conduct internal regulatory audit in preparation of the official audit, train local staff

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  Ministry of Health Israel

  Jan 2010 - May 2012

  Food inspector in National Food Service

  • Responsible for all aspects of quality and regulatory control and food safety, includingproduction, packaging and shipping, from raw materials to finished goods, sanitation, GMP’s.• Consultant to the Divisional Head of Public Health on GMP and production permits.• Provide professional advice to entrepreneurs during manufacturing plant planning stage.• Conduct field surveillance, collect and prepare evidence for court proceedings.• Manage a border crossing station, regulatory control of pre-packed food and raw material.• Daily cooperation with all levels of professional and law personnel, local authorities, etc. Show less

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  Omrix Biopharmaceuticals

  May 2012 - Sept 2019

  • Supplier relation management of EMEA Supply Base for Suppliers and External Manufacturing (EM):o Assure Performance and Compliance of suppliers and uses as Main contact for supply base and related quality system records (Change, NC, CAPA, etc.).o Represent SQ in cross functional EM teams and within the global organization, conduct on site meetings with critical suppliers to improve relations, R&R based documentations, purchasing controls, projects deliverable, addressing potential risks, quality agreement negotiation etc.• Oversee and manage Quality Systems (QS) at SQ level including: Non conformances (NC), Corrective and Preventive Action (CAPA), Internal/External Audit (IA/EA) Observations, Product Quality Escalation/Issues (PIA/PIE), Quality System Management Review (QSMR/DRB/MRB), Special Process Requests (SPR), Supplier Failure Investigation (SFIR) and other assigned SQ activities to ensure Quality Records are addressed with compliance:o Represent SQ in internal and external regulatory and compliance inspections.o Identify major millstone and hold backs in Quality record life cycle, export comprehensive reports, escalate to senior managemento Provide routine monthly records status analysis to support reporting of Quality System (QS) Metrics.o Quality lead in improvement projects for supplier reliability and monitoring of supplier development.o Participate in Data/Management Review Board DRB/MRB and Ad Hoc Meetings Represent SQ department, providing reports, escalate major issues, follow up on relevant action items and provide feedback to the management.o Provide comprehensive reports, manage budget and expense yearly planning, reflect risks and issues to management. Show less The filed of bio-surgical combination products used for the control of bleeding, overall responsibility for Quality Assurance including:•Supervision and control of raw materials, clean rooms, weighing, warehouse storage, temperature controlled shipments, materials dispensing.•Reports: validation protocols and reports, deviation reports, annual reports and management reports•Audits: preparing for and leading internal and external audits. •Supplier management: audits, approval and investigation of suppliers deviations.•Writing and enforcing due process, root cause investigations, corrective and preventive actions•Release of incoming / outgoing deliveries of APIs and raw materials (powders, liquids, perishables)•Review and approve CAPA changes, validation protocols, layouts and blue prints•ERP inventory control including managing defective materials•Professional training and supervision of clean rooms staff including corrective instructions•Writing, improving of SOPs under GMP conditions.•Preparing for FDA, EU GMP Inspection and regularities approvals, practiced with planning a new manufacturing line, included graded clean rooms.•Project management as QA Lead from the design stage through qualification and validation to GMP and ISO: - Design and qualify sampling grade C clan rooms for raw materials release process; - Design and qualify logistic center: raw materials warehouse, loading bays and cold storage for drug substance. - Implementation of a new and innovative technology (a hood with an air flow screen barrier) which renders redundant the use of a clean room. •Lead a team comprised of representatives, from cross company manufacturing sites, collaborating on process globalization, lessons learned and improvements projects such as: - Implementation of Kinetic Temperature theory in warehouse monitoring - Initiating the reassignment of rejected materials and APIs to be used in R&D activities. - Company Cost improvement projects. Show less

  • Supplier Quality Lead

    Jul 2017 - Sept 2019

  • Quality engineer and projects Lead for Supply Chain

    May 2012 - Jul 2017
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  Johnson & Johnson

  Sept 2019 - now

  Source Supplier Quality Manager, External Manufacturing and Direct Materials

  Holds primary responsibility to provide global Source/Supplier Quality (SQ) assurance expertise, direction and guidance in the development, implementation and continuous improvement of SQ programs associated with the management of external manufacturers, material suppliers and service providers supporting business units in EMEA and NA. Provides SQ support in line with established J&J Medical Device (MD), industry and regulatory standards (e.g. QSR, ISO, EN, CFR, EudraLex and MD Directive requirements). Develops and monitor QA systems to ensure that all External Manufacturers as well as material and service provider meet their quality objectives with regards to supplier, process and product controls.Be responsible for the overall quality activities, including purchasing controls, associated with external manufacturers. Lead development, continuous improvement and implementation of purchasing control processes for assigned supply base that meet regulatory requirements and align with J&J MD standards.Recruit, develop and manage a high performing source quality global team(NA, EMEA, LTAAM, APAC) to achieve group’s objectives and project milestones as well as contractors’ budget to meet financial commitments.SQ Engineering support to external manufacturers including product non-conformances, verification/validation, complaints, product issues, CAPA and change management.Supplier audit program assurance (schedule, execution, follow-up, etc.). Supplier selection & approval, supplier evaluation in compliance with MD and Combination Products purchasing controls requirements. Quality Leadership support of outsourcing programs, product transfers, business and quality aims.Quality metrics, supplier performance and monitoring.Role involving project management, problem solving, and technical projects.High performing skills in negotiating and influencing decision makers, decision making skills, communication skills, judgement, tact and leadership skills. Show less