Introduction
Contract: Initial 1 year, extension planned
We are seeking a QA Specialist to support our client in being 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 (Peptides), 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 obsolescence of QA documents and quality agreements.
* Act as the 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 Chemistry; a 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.
Additional Details
Seniority level: Associate
Employment type: Contract
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing
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