Senior Quality Assurance Operations Specialist

Detalhes da Vaga

Career Opportunities: Senior Quality Assurance Operations Specialist (4145)Requisition ID4145-Posted -Portugal-Porto Join Our Mission to Improve Lives Worldwide Performs 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) definition and accomplishment;
- Accountable for 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 in cross-functional teams on quality strategic and continuous improvement projects.
What You'll Bring - Degree in Pharmaceutical Sciences, Chemical Engineering or similar.
- Typically requires 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.

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Salário Nominal: A acordar

Fonte: Jobleads

Função de trabalho:

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