Responsibilities:
Act as the QA Qualification point of contact within project teams for new installations, facility upgrades, or system implementations, ensuring alignment with qualification standards.
Align various QA objectives, such as process and cleaning validation requirements, across cross-functional project stakeholders during execution phases.
Lead the roll-out of updated qualification approaches and confidently make decisions in complex quality matters when required.
Prepare, evaluate, and approve qualification-related documentation, including but not limited to URS, qualification master plans, design/installation/operational/performance qualification reports (DQ/IQ/OQ/PQ), and risk assessments like FMEA.
Review and authorize technical change controls throughout project stages and operational lifecycle, ensuring continued qualification compliance of systems, utilities, and equipment.
Serve as a subject matter expert for qualification topics during audits by clients and health authorities.
Manage quality deviations, ensure thorough investigations, and oversee timely closure of CAPAs and effectiveness evaluations.
Requirements:
University degree in a scientific or technical discipline such as Biotechnology, Chemistry, or Engineering.
Proven experience with qualification activities in the pharmaceutical sector.
Familiarity with cGMP guidelines and regulatory expectations is advantageous.
Solid understanding of manufacturing and technical operations.
Competence in identifying quality issues within project execution and taking corrective action.
Proficiency in both English and German is essential.
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