Calibration and Compliance Specialist GMP

Background

The Synthetic Molecules Technical Development (PTDC) department combines comprehensive expertise in the areas of Drug Substance (DS), Drug Product (DP), Analytical Sciences, as well as Manufacturing Science & Technology. In close cooperation with Research, Early Development, and Global Technical Development, PTDC contributes significantly to developing effective medicines from synthetic molecules.

The Plant Support & Compliance (PTDC-T) team ensures calibration, infrastructure, operational safety, and technical projects for the Drug Substance and Drug Product areas. In doing so, the team makes a decisive contribution to reliable plant operation and compliance with regulatory requirements in the GMP environment.

Your Tasks

• Execution of calibrations on manufacturing plants, analytical devices, and monitoring systems in the areas of Drug Substance (DS) and Logistic Solutions (PS)
• GMP-compliant documentation of all calibration activities
• Planning and coordination of calibration measures in close cooperation with internal stakeholders and external service providers
• Management of the testing equipment inventory, including new intake, certification, and decommissioning
• Maintenance and updating of calibration master data in BMRAM, SAP, and SAP S/4HANA
• Creation, revision, and maintenance of calibration instructions as well as Standard Operating Procedures (SOPs)
• Support with Changes, Deviations, as well as Corrective and Preventive Actions (CAPA)
• Further development and ensuring of calibration support for development and commercial production areas

Your Profile

Technical Qualifications

• Completed vocational training in the technical or pharmaceutical field, for example as:
• Chemistry or pharmaceutical technologist
• Pharmaceutical technician
• Chemical technician
• Automation technician
• or comparable qualification
• At least three years of professional experience in a GMP-regulated environment, preferably in production and/or development
• Sound knowledge of cGMP requirements and their practical application
• Strong technical understanding of chemical manufacturing plants as well as their automation systems
• Ideally experience in the calibration of measuring and process instruments
• Knowledge in the manufacture of non-sterile active ingredients is an advantage
• Experience with SAP, SAP S/4HANA or comparable systems desirable
• Very good German language skills as well as good English language skills in spoken and written form

Personal Competencies

• Independent, responsible, and structured way of working
• High level of initiative, integrity, and reliability
• Strong teamwork skills as well as high social competence
• Solution-oriented thinking and action with a focus on quality and customer satisfaction
• Ability to critically question processes and drive continuous improvements
• Fact-based decision-making and consistent implementation of measures
• Openness towards digital technologies and willingness for continuous further training
• Courage to actively address challenges and constructively contribute different perspectives

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