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For our client, a leading company in the pharmaceutical sector, we are seeking an Asset Excellence Manager.
In this role, you will be responsible for coordinating compliance activities related to the facilities, processes, and manufactured products within their area. In addition to GMP compliance, ensuring the most trouble-free and stable inspection possible is another focus, which is achieved through independent and continuous improvements.
General Information:
* Latest Start Date: 15.09.2025
* Planned duration: until 30.09.2026
* Extension: rather unlikely
* Home Office: max. 20%
* Working hours: Standard (can include on-call duty)
Tasks & Responsibilities:
* Process activities & production workflows: Optimization, testing, contact person for processes & systems, participation in launches, transfer projects & process validations, definition of production & process workflows
* Batch record review: Checking for completeness & accuracy of batch records, forwarding documentation to QA & batch completion
* MES activities & documentation management (PQS): Creation & testing of recipes & manufacturing instructions, coordination & approval of master batch records, creation & maintenance of GMP documents, ensuring current PQS processes
* Deviation & change management (deviations, complaints, CAPAs, changes): Processing of events, deviations & complaints as owner or SME, conducting root cause analyses (RCA) & trend analyses, processing of changes and CAPAs as change/CAPA owner
* Inspection management: Representing the department as an SME during inspections & audits, preparing, coordinating & accompanying inspections/audits (internal) & external), coordination of action tracking and timely processing
* Quality Risk Management (QRM): Responsibility for the QRM process within the scope of application, support as an SME (approver)
* Training & Trainings: Creation of training and training concepts, organization and implementation of training courses, management of training profiles, assumption of tasks as a "training partner"
* Project Management: Management, coordination, support and collaboration in local and global projects
* KPI, LPS & Standardization: Regular review of key performance indicators and derivation of improvements, application of LPS tools, support of problem solving, alignment and harmonization between teams, participation in relevant planning and control meetings
* Safety & Environmental Protection: Ensuring compliance with safety and environmental regulations, promoting operational safety and implementing accident prevention measures
Must Haves:
* Completed pharmaceutical, scientific, or technical studies or vocational training combined with at least 2 years of professional experience
* Professional experience preferably in microbiological area of pharmaceutical production, development, quality assurance, or quality control
* Experience in a GMP-regulated environment, including handling deviations
* Experience in Batch Record Review
* Excellent written and verbal communication skills in German and English
* High level of commitment to the position and the employer, openness to new ideas, resilience and flexibility, as well as consistent performance despite changing requirements
* Experience with MES and quality management systems
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Contract
Job function
* Job function
Quality Assurance
* Industries
Staffing and Recruiting
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