Quality Assurance Specialist

3 semanas atrás


Loures, Lisboa, Portugal Hovione Tempo inteiro

Join a Market Leader

Hovione is a leading international 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. We have a diverse team of over 1950 members from 36 different nationalities, located across Asia, Europe and North America.

Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients.

Key Responsibilities:

  • Participate in the definition of in-house quality procedures, standards and/or specifications;
  • Work with operational departments to establish procedures, standards and systems that assure and improve compliance with the GMPs;
  • Participate in Product/Project team work, delivering as per agreed timelines and needs under the scope of the Quality Assurance activity;
  • Assess health authorities, customer and industry requirements and ensure that these are met;
  • Prepare and review quality related documentation;
  • Specify quality requirements of raw materials with suppliers;
  • Write technical and Quality performance indicators reports;
  • Approve quality related documentation;
  • Approve batch documentation following internal procedures;
  • Participate in investigations, close deviations and propose CAPAs;
  • Propose, participate and assess changes to established procedures or processes;
  • Prepare and approve Quality Risk Assessments;

Requirements:

  • A university degree in Chemistry, Chemical Engineering, Pharmacy, or equivalent degree in a scientific area;
  • A proactive candidate with ability to lead complex matters to closure;
  • English fluency (written and oral).

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