We are currently looking for an Asset Excellence Manager that will play a pivotal role in ensuring GMP compliance across facilities, processes, and products. Your mission is to drive continuous improvement and maintain inspection readiness, ensuring smooth and stable operations. This role requires a deep understanding of operational processes, strong project management skills, and the ability to lead compliance initiatives across departments.
Responsibilities:
Process & Production Optimization : Lead improvements in production processes, support product launches, transfers, and validations, and act as a key contact for systems and process-related topics.
Batch Record Review: Ensure completeness and accuracy of batch documentation and coordinate with QA for batch release.
MES & Documentation Management: Create and test recipes and manufacturing instructions, manage GMP documentation, and ensure alignment with PQS standards.
Deviation & Change Management: Handle deviations, complaints, CAPAs, and changes as owner or SME, including root cause and trend analyses.
Inspection Readiness: Represent the department during internal and external audits, coordinate preparation and follow-up actions.
Quality Risk Management (QRM): Lead QRM processes and provide SME support for risk assessments and approvals.
Training & Development: Design and deliver training programs, manage training profiles, and act as a training partner.
Project Management: Drive and support local and global projects, ensuring alignment with strategic goals.
Performance & Standardization: Monitor KPIs, apply Lean Production System (LPS) tools, and support cross-team harmonization and problem-solving.
Safety & Environmental Compliance: Promote a safe working environment and ensure adherence to safety and environmental regulations.
Must-Haves: Degree in pharmaceutical, scientific, or technical disciplines, or equivalent vocational training with at least 2 years of relevant experience.
Proven experience in a GMP-regulated environment, particularly in pharmaceutical production, microbiology, quality assurance, or quality control.
Strong background in deviation handling and batch record review.
Proficiency in MES and quality management systems.
Excellent communication skills in bothGerman and English.
High level of commitment, adaptability, and resilience in a dynamic environment.
Duration: 12 months
Start date: ASAP
Ifyouwanttolearnmoreaboutthisopportunitypleasefeelfreetoreachoutdirectlyto mbertrand@actalentservices.com.
*While we appreciate every application, please note that due to the high volume of responses, we may only be able to contact shortlisted candidates
Job Title: Asset Excellence Manager
Location: Kaiseraugst, Switzerland
Job Type: Contract
Aerotek, an Allegis Group company. Allegis Group AG, Aeschengraben 20, CH-4051 Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available at https://www.allegisgroup.com/en-gb/privacy-notices.
To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to https://www.allegisgroup.com/en-gb/privacy-notices.
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