Sr. QA Associate

Client

Our client offers consulting and engineering for demanding projects in the industrial and life science sectors.

A minimum of 4-6 years working senior experience in a quality role in the biotechnical or pharmaceutical industry.
Bachelor’s or higher degree in Biochemistry, Biology, Pharmaceuticals, or other relevant education.
Excellent understanding and application of Global Regulatory guidelines.
Independent problem solver in a complex environment, balancing business need, regulatory requirements, and cost efficiency for all Quality decisions.
Ability to drive teamwork in a fast-paced environment.
Empowered professional who drives a Quality Mindset and can make well motivated pragmatic decisions on their own.
Experience in Tech Transfer and Risk Assessments have a strong preference.
Proficiency in English both in word and in writing.

You ensure compliance with all regulatory and GMP requirements.
Set GMP standards and provide guidelines for GMP processes such as Tech Transfer and Process Qualifications.
You take the lead in Quality Risk Assessments.
Take the lead in setting up the Quality processes and its documentation systems.
Act as a Quality expert for regulatory submissions and inspections.
Quality review and approval of GMP documentation.
Support and approve non-conformance investigations and appropriate corrective/preventive action plans.