- Location
- Reykjavik Headquarters, Iceland
- Type
- Full-time
- Department
- IT
- Seniority
- Senior
- Experience
- 3+ years
- Education
- Bachelor
- Closing date
- Today
- Source
- Workday
Description
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.
Skills
GMP
