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    Supplier Quality Assurance Specialist - Lisbon, Portugal - Hovione

    Hovione
    Hovione Lisbon, Portugal

    há 5 dias

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    Descrição

    Join a Market Leader

    Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.

    Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.

    Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.

    You will be responsible to:

    Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Provides global supplier qualification services in support of new product introduction and existing products. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.

    Manage Quality Agreements with suppliers: preparation, interaction with supplier, improvements, workflow approval and revision

    Prepare and review procedures, templates, aide-memoires and methodologies to standardize practices related to supplier's qualification

    Conduct quality due diligences to the suppliers proposed by the buyers

    Perform supplier review assessments to assure compliance with Hovione requirements including verification of supplier questionnaires, declarations and certifications, audits output, quality agreements, quality review of product/ service provided and feedback from other team members

    Approve/Reapprove supplier qualification processes (SMS)

    Manage Customer Direct Buy (CDB) materials

    – Ensure, with each Project team QA member, that when materials or services suppliers are selected and qualified by customers the suppliers chosen comply with Hovione requirements

    Manage or Participate in suppliers' audits, executing the several audit steps

    Issue complaints to suppliers and perform CAPA completions follow-up

    Participate with internal project teams in investigations and root cause analysis determination to support supplier complaints

    Participate in the definition of key performance indicators of the area

    Collect supplier quality metrics for management oversight review and work to improve supplier quality metrics by driving improvement plans with suppliers

    Participate in client audits and Health Authorities inspections, responding for procedures, methodologies, supplier qualification processes, complaints and all activities approved by SQA

    Coach other areas of the organization on supplier qualification methodologies and requirements

    Ensure all assigned tasks are properly planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner

    Propose improvements to the area as appropriate and solve problems

    Make quality and timely decisions within the supplier quality assurance tasks under her / his responsibility

    Gather relevant data to inform the decision makers regarding complex issues

    Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione ́s policies, systems and procedures (COPs, HBR, SOPs and others)

    Track supplier quality performance and report to management and suppliers

    Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

    We are looking to recruit a Candidate:

    University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field (mandatory)

    Typically requires 3-5 years of relevant experience in Quality Assurance, preferably in a GMP environment (Pharmaceutical Industry preferred)

    Strong understanding and knowledge of Quality aspects applied to suppliers, auditing suppliers in the Pharmaceutical Industry, cGMP, ICH guidelines and GDP

    Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.

    Fluency in English is a requirement

    Computer literate with good working knowledge of the MS Office package

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