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Senior Product Complaint Specialist

Alvotech hf · Reykjavik Headquarters, Iceland, United States

Imported listingfull-time6 days ago

About The Role

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.

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