IT i tehnologija
Senior Product Complaint Specialist
IN10 Alvotech Biosciences India PVT Ltd
Reykjavík, IslandPuno radno vrijeme
We are looking for a Senior Product Complaint Specialist who will be responsible for leading investigations related to Product Quality Complaints (PQC), while also supporting deviation, OOS, and other quality event investigations in a GMP-regulated pharmaceutical environment. The role ensures investigations are conducted in a timely, compliant, and scientifically sound manner, identifying root causes and driving effective corrective and preventive actions (CAPAs), reporting to QA Investigations Manager. Key Responsibilities • Lead, conduct and document Product Quality Complaint investigations from initiation through closure. • Perform root cause analysis using structured investigation tools and methodologies. • Assess product impact and support risk evaluations. • Develop, implement, and track CAPAs to completion. • Collaborate with Manufacturing, Suppliers, Quality Control, Engineering, Supply Chain, and other functions to gather information and drive investigation outcomes. • Ensure investigations are completed in accordance with GMP requirements, company procedures, and established timelines. • Identify and recommend continuous improvement opportunities within the Quality Management System. Qualifications & Experience • Bachelor's degree in scientific discipline such as Chemistry, Microbiology, Pharmacy, Biochemistry, Engineering, or a related field. • Minimum 3 years of investigation experience within a GMP pharmaceutical or biotechnology environment. • Experience conducting Product Quality Complaint, deviation, OOS, and CAPA investigations. • Strong understanding of cGMPs, quality systems, and regulatory expectations. • Proficiency in root cause analysis and risk assessment methodologies. • Excellent written communication, analytical, and problem-solving skills. • Ability to manage multiple investigations and work effectively in a cross-functional environment. What we offer: • An inspiring challenge to work with great co-workers on ambitious projects that change people's lives. • The chance to be a part of a global and fast-growing company. • An international work culture that encourages diversity, collaboration, and inclusion. • Positive, flexible, and innovative work environment. • Support for personal growth and internal career development. • Company social events and milestone celebrations. • Excellent in-house canteen and coffee house. • Exercise and well-being support for full-time employees. • On-site shower facility. • Transportation grant towards eco-friendly modes of travel for full-time employees. • Internet at home for full-time employees. Originally posted on startup.jobs: https://startup.jobs/senior-product-complaint-specialist-in10-alvotech-biosciences-in-10432282?utm_source=mcp&utm_medium=mcp
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