Talent Acquisition Consultant at Coopers Group AG - Life Science
Contract duration: 1 year/possible extension
This 1-year contract position (with possible extension) focuses on monitoring and ensuring the GMP‑compliant operation of critical pharmaceutical media systems such as purified water and gases. The role is responsible for independently creating and interpreting trend reports, identifying early deviations, and initiating preventive actions. Key tasks include data analysis, KPI evaluation, logbook reviews, and ensuring data integrity. The position supports regulatory compliance by managing deviations, changes, and CAPAs within Quality Veeva Vault, preparing for inspections, and coordinating SMEs during audits.
Acting as a GMP Coach, the role provides guidance and training to operational teams, supports implementation of Pharma Quality System (PQS) requirements, and contributes to SOP development and documentation management.
Responsibilities
* Monitoring & Trending: Independent creation, evaluation, and interpretation of trending reports for critical process media (PW, gases). Identify trends early (Out of Trend – OOT) and initiate preventive measures before limits are exceeded.
* Data Analysis: Assess key performance indicators (KPIs) for operational compliance and conduct logbook checks, as well as reviewing monitoring data for plausibility and data integrity.
* Compliance Assurance: Ensure compliance with official and regulatory requirements in day-to-day operations and implement Pharma Quality System (PQS) requirements (GSP).
* Deviation Management: Initiate and process documents in the Quality Veeva Vault system (Deviation / Change / CAPA), particularly in the case of anomalies in media monitoring.
* GMP Support: Serve as the primary contact for employees with GMP‑related questions (GMP Coach) and support the Circles to ensure GMP‑compliant operations.
* Inspection Readiness: Ensure inspection readiness (front and back office) and coordinate Subject Matter Experts (SMEs) during regulatory inspections.
* Documentation: Process overarching SOPs and support the implementation of PQS requirements in the Process Management System documents.
* GMP Training: Conduct training sessions and support the Circles to ensure GMP‑compliant operations.
Requirements
* Completed technical degree or vocational training with relevant further education in the field.
* Fluent in German and English
* Minimum of 3 years of experience creating and interpreting trend analyses for pharmaceutical media systems (water, gases).
* Initial professional experience in a company with process water (WBI/WFI) and/or gas supply systems in a GMP environment, as well as knowledge of qualification and validation.
* Practical experience implementing technical GMP requirements of regulatory authorities (RHI, FDA, EMA, etc.) and processing deviations, changes, and CAPAs.
* Comfortable handling of quality data, understanding of alarm and action thresholds, and experience evaluating OOT/OOS results.
* Ability to identify cross‑system correlations from monitoring data and prepare reports with graphical precision and clarity.
* Excellent computer skills (MS Office, Google Suite). Advanced knowledge of Excel and Google Sheets is essential for efficient data processing and trend visualization.
* Experience conducting GMP training and instruction for operational staff.
* Ability to explain complex compliance topics clearly and understandably to enhance GMP understanding.
Additional Information
* Seniority level: Mid‑Senior level
* Employment type: Contract
* Job function: Quality Assurance
* Industries: Biotechnology Research and Pharmaceutical Manufacturing
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