Quality Complaints Specialist
Our client is a global biotechnology company specializing in innovative therapies. Renowned for groundbreaking research in life-changing treatments. Committed to improving patients’ lives through cutting-edge science. A leading force in the healthcare industry, driving advancements worldwide.
The Quality Complaints Specialist team manages the end-to-end global complaint process, ensuring compliance with quality standards and driving continuous improvement. Specialists lead cross-functional investigations, coordinate record closure plans, and maintain regulatory compliance while providing technical guidance and escalating issues as needed.
- Assist cross-functional meetings to strategize and synchronize the closure of records.
- Utilizing analytical acumen and product expertise to assess intricate scenarios via diverse information channels.
- Promptly raising concerns that might hinder the timely closure of records as per action plans.
- Adhering to both local and global processes and regulations.
- Executing regulatory and Standard Operating Procedure (SOP) obligations.
- Proactively identifying and averting potential regulatory challenges.
- Offering guidance and technical counsel.
- Assessing evaluations from subject matter experts.
- Doctorate degree or Master’s Degree or any relevant qualification or experience.
- 4+ years of experience in quality and manufacturing within the biotech or pharmaceutical industry.
- Proficiency in simultaneously overseeing multiple projects.
- Familiarity with fundamental project management tools.
- Knowledge of relevant manufacturing and testing processes, including API, Drug Substance, Drug Product, Packaging, and Device manufacturing.
- Willingness to travel up to 10% of the time.
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Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
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