GMP Process Expert

vor 15 Stunden

Kaiseraugst, Aargau, Schweiz Coopers Group AG Vollzeit

Contract duration: 12 months/possible extension

We are looking for a GMP Process Expert to join our team in one of the following areas: Solids, Antibiotics, Sterile Filling, Assembly & Packaging and Central Logistics Services. The position is designed to accompany the process and works as a supporting function for ensuring and optimising GMP-compliant processes in the respective area.

The GMP process expert is responsible for coordinating the activities for compliance with GMP specifications around the plants, processes and manufactured products in his area. In addition to compliance with and implementation of GMP requirements, the most trouble-free and stable production possible is another focus, which is achieved through independent and continuous improvements. This requires good knowledge of the operating processes and facilities as well as very good organizational skills for project processing.

Responsibilities:

  • Batch Record Review in Manufacturing Execution System (MES)
  • Processing of deviations, complaints, changes and CAPAs as well as carrying out root cause analyses.
  • Support of technical projects in the GMP environment
  • Production & Process Responsibility: Data-based analysis of key performance indicators to increase efficiency, quality assurance and process monitoring in production; Support with launches, transfers and process issues.
  • Documentation & Batch Management: Review of batch records, SAP accounting 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; Performing root cause analysis and trend analysis.
  • Inspection Management & Quality Risk Management (QRM): Preparation and support of audits/inspections; Responsibility for risk analyses and their moderation.
  • Training & Safety: Organization and implementation 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.

Requirements:

  • Completed pharmaceutical, scientific or technical studies, equivalent vocational training or professional experience with further training.
  • Fluent in German and English.
  • At least 2 years of professional experience in pharmaceutical production, development, quality assurance and control or a related industry // GMP production experience, pharmaceutical production / laboratory deviations & changes.

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