Quality Assurance Operations Specialist

Porto
Permanente
Horário completo

Há 1 mês

Join Our Mission to Improve Lives WorldwidePerforms quality oversight of BIAL Group and its subcontractors, according to GMDP, applicable guidelines, regulatory requirements and aligned with the company's strategy.The Impact You'll Make- Assure that GMDP operations are carried out in accordance with the applicable guidelines and regulatory requirements (eg. European and US);
- Contribute for Audit Program (internal and external) execution;
- Accountable for prepare, review and approve GMDP documents;
- Act as quality subject matter expert, supporting the quality oversight of BIAL group and its subcontractors;
- Provide GMDP training;
- Manage the electronic Quality Management System;
- Management of quality events;
- Collaborate on quality strategic and continuous improvement projects.What You'll Bring
- Degree in Pharmaceutical Sciences, Chemical Engineering or similar.
- Typically 3to 5 years of experience in a similar role or in a GMP operational area;
- Good knowledge of Quality, cGMP, cGDP and ICH guidelines;
- Experience in an FDA approved manufacturing site (preferential).
- Solid English skills (B2 minimum);
- Excellent communication skills and ability to enhance partnerships with internal and external stakeholders;
- Analytical mindset with strong attention to detail;
- Capable of setting priorities and quickly solve problems;
- Ability to adapt to a dynamic and fast-paced work environment. -experience in cross-functional teams and projects (preferential)Create Your Path@BIAL
“The innovative projects continue to motivate me, and the people as well because they are incredibly passionate about what they do, very curious, and unafraid to face the unknown.”
Miguel Fonseca (Senior Data Scientist, Portugal)JOIN US!To know more about BIAL, visit us on . Follow us on and

BIAL

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