Quality Assurance Associate

Job description

We are seeking a dedicated and detail-oriented Quality Assurance Specialist (remote). The successful candidate will play a crucial role in supporting the Supplier Quality organization by managing supplier-related activities and ensuring compliance with quality standards.

Your missions

• Maintain and update records related to external suppliers, including information on materials, qualifications, and monitoring activities.


• Assist in supplier assessments and manage supplier documentation, including:
  
  
  
  • Specifications agreements
  
  
  • Manage and oversee GMP deviations, including investigation and documentation
  
  
  • Follow-up on activities related to supplier performance
  
  
  • Support change control processes to ensure effective management of supplier changes.
  
  
  
  


• Supported the development and implementation of mitigation and remediation plans for Annex 1 compliance gaps identified during EQSM aseptic on-site assessments at key parenteral CMOs.


• Collaborated with cross-functional teams and CMOs to address findings from audits and proactive compliance assessments, ensuring timely and effective remediation aligned with current Annex 1 requirements.


• Ensure alignment of delays and potential capex with PES, EQ, MSAT and MQSA.


• Collaborate on projects as part of a team.

Your profile

• Scientific degree in a relevant field (Pharmaceutical Sciences, Biology, Chemistry, or related area).


• Proficiency in English (mandatory).


• Manage and oversee GMP deviations, including investigation and documentation


• Coordinate and review root cause analysis and risk assessments


• Ensure compliance with GMP requirements and support audits and inspections


• Strong organizational skills and attention to detail.


• Experienced in aseptic practices and Annex 1.


• Excellent written and verbal communication skills.

What we offer

• An international and multicultural work environment within a fast-growing consulting company.


• A clear career path with personalized growth opportunities (both vertical and horizontal).


• Continuous training and development programs through our internal Academy.


• The opportunity to contribute to innovative projects with leading international clients in the Life Sciences sector.

At Amaris Consulting, we believe that diversity is a strength and we are proud to be an equal opportunities employer. We welcome applications from all backgrounds and are committed to fostering an inclusive environment where every voice is heard and valued.