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Hovione

Hovione is an international company with over 55 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in Portugal, the U.S., Ireland and China, Hovione offers integrated API, particle design, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.

To reinforce our team we are looking to fill the following position at our Lumiar site:


Supplier QA Specialist (M/F)

The Supplier QA  Specialist will ensure that the quality aspects of the supplier qualification and maintenance at Hovione follows adequate standards and fits for the purpose. The established mission is followed and measured according with the right Key Performance Indicators that are regularly evaluated.


Main responsibilities:

  • Approve procedures, templates, aide-memoires and methodologies to standardize practices;
  • Approve/Reapprove supplier qualification processes (MASQ);
  • 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;
  • Disqualify suppliers;Participate in Supplier Audits (for the members of the audit pool) – execution and managing audit
    findings;
  • Manage complaints to suppliers related with quality;
  • Manage Quality Agreements with suppliers. Preparation, interaction with supplier, improvements, workflow approval and revision;
  • Participate in clientes audits and Health Authorities Inspections – responding for procedures, methodologies, supplier qualification processes, complaints and all activities approved by QA;
  • Manage supplier quality related events;

Profile:

  • University degree Chemical Engineer, Chemistry, Pharmaceutical Sciences or similar. Other degrees can be
    considered, depending of the past experience of the candidate;
  • Experience in Quality Assurance, Suppliers Knowledge related with Quality aspects and audits are
    advantages;
  • Good knowledge on GMP, ICH guidelines and GDP;
  • English proficiency;
  • Assertive, use common sense and business oriented;
  • Ability to stand and to discuss technical aspects with clients and suppliers;
  • Excellent written and verbal communication skills;

         

We offer:

  • Full time opportunity;
  • Remuneration and social benefits adjusted to the job function and matching the experience;
  • Excellent work environment, with a strong focus on quality.







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