Specialist Quality Complaints to:
Experience in quality and manufacturing and/or Product.
Development/Safety/Research experience in biotech or pharmaceutical industry.
Demonstrated skill in facilitating complex investigations from initiation to completion.
Knowledge of Root Cause Analysis (RCA) process.
Expertise in development management and complex investigations.
Combination products expertise.
Ability to negotiate a strategic position after taking feedback from multiple sources.
Experience with processes involved in manufacturing and distribution, QA, QC, validation, and processes development.
Facilitate cross-functional meetings to plan and coordinate the plan for closure of records.
Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information.
Maintains compliance with local and global processes.
Execution of regulatory and SOP requirements.
Requirements
- Doctorate degree or Master s degree & 3 years of experience directly related to the job or Bachelor degree & 5 years of experience directly related to the job.
- Technical Writings
- Bilingual (Writing and Spoken)
Doctorate degree or Master s degree & 3 years of experience directly related to the job or Bachelor degree & 5 years of experience directly related to the job. Technical Writings Bilingual (Writing and Spoken)