Ph3Job Description /h3 pThe 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. /p h3Responsibilities /h3 ul liReview and approval of SOPs, protocols, reports, Certificate of Analysis and other quality documents /li liSupport quality investigation of deviations and Out of Specification (OOS) /li liMaintenance, recording and processing of corrective and preventive measures (CAPA) /li liPerforming internal audits /li liOrganization and management of customer audits, and inspections /li liApply and interpret audit and compliance requirements /li liAct as QA point of contact for customers /li liSupport for GMP training /li /ul h3Qualifications /h3 ul liScientific education (Master degree) in analytical chemistry/ biochemistry/ life science /li liMulti-year, industrial work experience of 5 years minimum in the analytical-pharmaceutical environment preferably experience in QA /li liStrong problem-solving skills to meet business objectives /li liExcellent interpersonal skills and teamwork spirit /liliAbility to collaborate in a dynamic, cross-functional matrix environment /li liBroad knowledge and proven experience of the regulatory framework in the GMP environment (ICH, FDA, USP, Ph. Eur.) /li liSolid background in data integrity and computerized systems risk assessment and project support /li liExperience as an auditor is an asset /li liFluency in English, German is an asset /li /ul /p #J-18808-Ljbffr