Quality Assurance Specialist
3 semanas atrás
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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