Quality Assurance Operations Specialist Trofa

Quality Assurance Operations Specialist
Trofa
Trofa, Porto, Portugal

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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 (e. g. , European and US);
• Contribute to the Audit Program (internal and external) execution;
• Prepare, review, and approve GMDP documents;
• Act as a quality subject matter expert, supporting the quality oversight of BIAL group and its subcontractors;
• Provide GMDP training;
• Manage the electronic Quality Management System;
• Manage quality events;
• Collaborate on quality strategic and continuous improvement projects.

What You’ll Bring

• Degree in Pharmaceutical Sciences, Chemical Engineering, or similar;
• Typically 3 to 5 years of experience in a similar role or in a GMP operational area;
• Good knowledge of Quality, c
  GMP, c
  GDP, and ICH guidelines;
• Experience in an FDA-approved manufacturing site (preferential);
• 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 solving problems;
• Ability to adapt to a dynamic and
  - paced work environment; experience in
  - 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. ”

Seniority level

• Associate

Employment type

• Full-time

Job function

• Quality Assurance

Industries

• Pharmaceutical Manufacturing

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