# GMP Specialist & EAMS Administrator **Company**: Pfizer **Location**: Orth **Work arrangement**: hybrid **Job type**: full-time **Salary**: € 4,355.55 **Category**: Engineering **Industry**: Healthcare **Apply**: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/Austria---Orth/GMP-Specialist---EAMS-Administrator--m-w-d-_4965617-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_a3c45eb2-56b ## Description Do you want to change the lives of millions of people with joy, innovation, and our highly qualified team? Pfizer is a global organisation that works to maintain or improve human health. Our BSL3 laboratory in Orth, one of the largest in Europe, produces active ingredients for around 14.5 million vaccine doses per year. **Job Summary:** We are seeking a GMP Specialist & EAMS Administrator to join our team in Orth an der Donau. **Responsibilities:** ### GMP & Quality Management - Ensure GMP compliance in the Engineering Services & Utilities (ESU) area and act as a central point of contact for GMP-related topics. - Create, edit, and coordinate deviations, including documentation, root cause analysis, and definition and follow-up of effective measures. - Take responsibility for creating and editing Change Controls as Change Owner and coordinate required activities. - Define, edit, and track CAPAs and other measures from deviations, changes, audits, and GMP activities. - Conduct and coordinate formal GMP checks and reviews of SOPs, work instructions, forms, and other ESU documents. - Create, revise, and maintain GMP-relevant documents and ensure timely processing. - Provide advice to ESU team members on GMP and documentation issues and promote consistent, compliant working practices. - Coordinate GMP-related activities, particularly Quality Risk Management. - Prepare for and accompany internal and external audits or inspections, including presentation of relevant content and follow-up of measures. - Contribute to projects and continuous improvement and standardisation of processes, taking into account GMP, documentation, and data integrity. ### EAMS Administration - Central responsibility for the administration and support of the calibration and maintenance database EAMS (Enterprise Asset Management System) together with a team colleague. - Maintain, check, and administer relevant master data and support maintenance and calibration processes in EAMS. - Act as a point of contact for EAMS-related questions, data maintenance, and system-supported processes. - Ensure data quality and data integrity and continuously improve and standardise EAMS processes. **Requirements:** - Completed technical or scientific training, e.g., HTL, FH or university in engineering, process technology, biotechnology or a comparable field; alternatively, relevant professional experience in a GMP environment. - Knowledge or practical experience in a GMP-regulated pharmaceutical environment, ideally in the technical or engineering area. - Understanding of GMP quality systems, particularly deviation management, change control, CAPA and document management. - Experience with EAMS or a comparable maintenance and calibration database is beneficial but not essential. - Basic understanding of utilities, technical systems, maintenance, and engineering processes. - Pronounced GMP and data integrity awareness. - Structured, careful, and independent working style and high quality and sense of responsibility. - Analytical and solution-oriented way of working. - Good organisational ability and joy in reliably coordinating several topics and deadlines. - Enjoyment of working together in interdisciplinary and cross-functional teams. - Clear communication and the ability to convey GMP requirements understandably and pragmatically in everyday engineering. - Good German and English language skills in writing and speaking. **What We Offer:** - A free company bus between Vienna Donauzentrum and the Orth an der Donau site, several times a day in both directions (connection to metro lines U1 and U2). - A company restaurant. - Diverse career and development opportunities. - Corporate health promotion. - The opportunity to get involved socially within the framework of corporate volunteering. - A flexible working time model. - Home office possibility depending on the position and operational requirements. - An open and appreciative corporate culture. The minimum salary for this position is € 4,355.55 gross based on full-time employment. A possible overpayment depends on relevant professional experience and qualification. ## Skills ### Required - GMP - Quality Management - Engineering - EAMS Administration - Calibration - Maintenance - Data Integrity - German ### Nice to have - EAMS - Change Control - CAPA - Deviation Management - Documentation --- Source: [Apply at pfizer.wd1.myworkdayjobs.com](https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/Austria---Orth/GMP-Specialist---EAMS-Administrator--m-w-d-_4965617-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)