Quality Complaints Specialist
The Company
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.
Role Description
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.
Responsibilities

• 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.

Requirement

• 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.

Other Information
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