Supplier Quality Assurance Specialist
2 meses atrás
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.
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.
- 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
Hovione is a proud Equal Opportunity Employer Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.
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