- Company Name
- UPSA
- Job Title
- Responsable Monitoring & Maitrise des Standards H/F - (CDI)
- Job Description
-
**Job title**
Monitoring & Standards Management Manager (M/F) – Permanent
**Role Summary**
Lead process investigation, root‑cause analysis, and dynamic monitoring to ensure robust pharmaceutical manufacturing. Collaborate cross‑functionally with Business Units (BUs) to develop, implement, and verify action plans that maintain or restore product and process standards.
**Expectations**
- Apply scientific and statistical expertise to diagnose performance issues and drive corrective actions.
- Champion continuous improvement, quality, and productivity initiatives across multiple disciplines.
- Act as a trusted advisor and training leader for RCA, investigation tools, and robust process design.
- Demonstrate strong leadership, influence, and communication skills in a fast‑changing environment.
**Key Responsibilities**
- Investigate process performance problems; design and execute corrective action plans.
- Conduct effectiveness reviews, recurrence analysis, and monitor post‑action outcomes.
- Lead cross‑functional teams in RCA implementation and action plan development.
- Implement VCP (voluntary control program) approach: risk analysis, critical parameters, AQC definition, data‑collection tools, and statistical monitoring.
- Develop and maintain dynamic monitoring systems (control charts, capability indices, KPIs).
- Define deviation‑handling procedures and adjust control limits as needed.
- Prepare monitoring reports with risk‑based product analysis and recurrence tracking by product and trimester.
- Share trend analyses, lessons learned, and action plans with impacted functions.
- Support BUs on reliability projects: deviation resolution, robustness enhancement, performance improvement.
- Provide training and support for processes, RCA, and investigative tools.
- Lead incident management involving performance impact: root‑cause identification, technical action plan support, implementation assistance.
**Required Skills**
- Advanced statistical analysis and data interpretation.
- Root‑Cause Analysis (RCA) methodology and facilitation of investigations.
- Expertise in manufacturing process design: QbD, Design Space, AQC, critical parameters.
- Knowledge of regulatory frameworks: ICH Q8, Q9, Q10.
- Strong facilitation, communication, and cross‑functional team management.
- Ability to plan, prioritise, and execute multiple simultaneous activities.
- Proficient in English (written & spoken).
- Demonstrated leadership and influence in process improvement contexts.
**Required Education & Certifications**
- Pharmacist with thesis OR Engineer with 3–5 years experience in pharmaceutical process investigation/monitoring.
- Relevant certifications in process analytical technology (PAT), statistical quality control, or continuous improvement (e.g., Six Sigma Green/Black Belt) are an advantage.
- Certification or proven knowledge of ICH Q8, Q9, Q10 regulatory requirements.