Introduction:
We are seeking a
QA Specialist
to support our client to be the POC with the CMO for
Drug Substance (DS) manufacturing.
Your focus would be on
GMP/GDP compliance, batch release, supplier oversight, and quality system management
while supporting senior QA leadership. This role involves working closely with a local DS supplier and coordinating shipments to global locations, so
fluency in German
is highly desirable.
Key Responsibilities:
- Oversee Drug Substance manufacturing quality , including batch record review, disposition, method validation, risk assessments, and change controls.
- Manage deviations, CAPAs, investigations, and effectiveness checks to ensure compliance with internal and regulatory requirements.
- Support supplier and customer qualification , including audits, due diligence, and compliance with GMP/GDP standards.
- Maintain and manage quality documentation , including creation, review, approval, archival, and obsoletion of QA documents and quality agreements.
- Act as QA point of contact for daily operations, including participation in meetings, cross-functional projects, and internal quality system oversight.
- Participate in regulatory inspections, audits, complaint and recall management, and continuous improvement initiatives .
Requirements:
- Bachelor’s or Master’s degree in Life Sciences or related discipline; PhD is a plus.
- Minimum 2 years’ QA experience in a regulated pharmaceutical or biotech environment, with strong knowledge of cGMP and GDP regulations.
- Fluent in English and German , with experience managing documentation and quality oversight in Switzerland; Drug Substance or QC/manufacturing experience preferred.