GMP Process Expert

Manufacturing Units Sterile Filling, Antibiotics, Packaging & Assembly, Central Logistics Services and Solids in Kaiseraugst is looking for a GMP Process Expert to strengthen their team in one of the following areas: Solids, Antibiotics, Sterile Filling, Assembly & Packaging and Central Logistics Services. This position is process-oriented and not operationally involved with the equipment. Instead, it serves as a support function to ensure and optimize GMP-compliant processes within the respective area.

At Kaiseraugst production site, the Solids Manufacturing Unit is responsible for the production and packaging of various solid dosage forms, including film-coated tablets, capsules, and granules for oral suspensions.

The GMP Process Expert is responsible for coordinating activities related to GMP compliance for the equipment, processes, and manufactured products within their area. Maintaining a smooth and stable production flow, in addition to adhering to and implementing GMP requirements, is a key focus, achieved through independent and continuous improvement. This requires a thorough understanding of operational processes and equipment, as well as excellent organizational skills for project management.

Your Profile:

• Hold a degree in pharmacy, natural sciences, or engineering, along with relevant professional experience in pharmaceutical production, development, quality assurance, and control.
• Excellent written and spoken German and English skills are essential.
• High level of commitment, openness to new ideas, resilience, flexibility, and consistent performance under changing demands.

Tasks & Responsibilities:

• Batch Record Review in Manufacturing Execution System (MES)
• Processing deviations, complaints, changes, and CAPAs, as well as conducting root cause analyses
• Supporting technical projects in a GMP environment
• Production & Process Responsibility: Data-driven analysis of key performance indicators for efficiency improvement, quality assurance, and process monitoring in production; support with launches, transfers, and process-related issues.
• Documentation & Batch Management: Review of batch records, SAP posting control, and management of GMP documents.
• Manufacturing Execution System (MES): Creation, testing, and maintenance of recipes, manufacturing instructions, and master batch records.
• Quality & Deviation Management: Processing of Deviations, Complaints, Changes, and CAPAs; conducting root cause analyses and trend analyses.
• Inspection Management & Quality Risk Management (QRM): Preparation and support of audits/inspections; responsibility for risk analyses and their moderation.
• Training & Safety: Organization and execution of training courses; ensuring occupational safety and environmental protection in the area.
• Projects & KPIs: Support for technical projects in the GMP environment with associated documentation; KPI review, standardization and use of LPS tools, process improvement.

Must-haves:

• Completed degree in pharmacy, natural sciences, or engineering, equivalent vocational training, or professional experience with further education
• At least 2 years of professional experience in pharmaceutical production, development, quality assurance and control, or a related industry // GMP production experience, managing pharmaceutical production/laboratory deviations & changes
• High level of commitment to the position and the employer, openness to new ideas, resilience and flexibility, as well as consistent performance under changing requirements, ideally, GMP experience
• Excellent written and spoken communication skills in German (at least C1 level) and English.

Sounds interesting? Apply Now! We look forward to receiving your application. 

Application Submission Deadline: 04.11.2025