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:

1. Oversee Drug Substance manufacturing quality , including batch record review, disposition, method validation, risk assessments, and change controls.
2. Manage deviations, CAPAs, investigations, and effectiveness checks to ensure compliance with internal and regulatory requirements.
3. Support supplier and customer qualification , including audits, due diligence, and compliance with GMP/GDP standards.
4. Maintain and manage quality documentation , including creation, review, approval, archival, and obsoletion of QA documents and quality agreements.
5. Act as QA point of contact for daily operations, including participation in meetings, cross-functional projects, and internal quality system oversight.
6. Participate in regulatory inspections, audits, complaint and recall management, and continuous improvement initiatives .

Requirements:

1. Bachelor’s or Master’s degree in Life Sciences or related discipline; PhD is a plus.
2. Minimum 2 years’ QA experience in a regulated pharmaceutical or biotech environment, with strong knowledge of cGMP and GDP regulations.
3. Fluent in English and German , with experience managing documentation and quality oversight in Switzerland; Drug Substance or QC/manufacturing experience preferred.