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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.
Job Responsibility:
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
Requirements:
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