Job Description
The Quality Assurance Specialist plays a central role in ensuring quality, compliance, and regulatory excellence in a GMP-controlled environment. The position contributes directly to business success by reviewing and approving key quality documentation and supporting investigations, CAPAs, and audits. Working closely with internal teams and customers, the role acts as a trusted QA partner in daily operations. It offers broad exposure across quality topics, strong stakeholder interaction, and the opportunity to actively shape compliant processes in a dynamic environment.
Responsibilities
* Review and approval of SOPs, protocols, reports, Certificate of Analysis and other quality documents
* Support quality investigation of deviations and Out of Specification (OOS)
* Maintenance, recording and processing of corrective and preventive measures (CAPA)
* Performing internal audits
* Organization and management of customer audits, and inspections
* Apply and interpret audit and compliance requirements
* Act as QA point of contact for customers
* Support for GMP training
Qualifications
* Scientific education (Master degree) in analytical chemistry/ biochemistry/ life science
* Multi-year, industrial work experience of 5 years minimum in the analytical-pharmaceutical environment preferably experience in QA
* Strong problem-solving skills to meet business objectives
* Excellent interpersonal skills and teamwork spirit
* Ability to collaborate in a dynamic, cross-functional matrix environment
* Broad knowledge and proven experience of the regulatory framework in the GMP environment (ICH, FDA, USP, Ph. Eur.)
* Solid background in data integrity and computerized systems risk assessment and project support
* Experience as an auditor is an asset
* Fluency in English, German is an asset
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