QA Associate (Global biopharmaceutical firm, Tokyo, 6-8m)
Join a company that feels passionate about helping patients
Be part of multidisciplinary teams, taking quality as the core value
Our client is a global biopharmaceutical company which main mission is to transform the lives of patients with serious and rare diseases. The employees work with a profound sense of urgency to deliver technologies and medicines in therapeutic areas with the greatest potential to make a difference in patients' lives.
- Ensure accurate and thorough complaint intake information, replacement need, troubleshooting with complainant, complainant follow-ups, product complaint investigations, tracking and trending of complaint data.
- Review each complaint assigned for accurate/missing information, complaint details, further regulatory compliance actions, replacement needs, or unreported adverse events.
- Act as technical product subject matter expert and trouble shoot complaints with complainants.
- Contact complainants for complaint follow up information, troubleshooting, and medical device replacement and returns.
- Provide relevant medical device complaint information to the medical device manufacturer.
- Perform complaint investigations to determine root cause, identify resolution and respond to the complainants.
- Issue complaint close-out notifications to complainants.
- Report issues, assist in resolution and improvement activities.
- Actively work on product/supplier deviations and CAPAs, assisting with technical write up, impact assessment, and root cause analysis.
- Assist in maintaining the applicable QMS SOPs.
- Report quality metrics on a monthly basis as they relate to batch release, complaints, deviations, CAPAs', change requests or other relevant quality metrics.
- Minimum 3 years' experience in a similar role within pharmaceutical or medical device industry.
- Thorough knowledge of GMP, GQP, and good documentation practice.
- Excellent communication skills (verbal and written) in Japanese and English.
- Highly organised with a strong attention to detail, clarity, accuracy and conciseness.
- Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter.
- Works effectively across functions as a team player.
- An uncompromising ethical standard and level of conduct are essential.
- Working in a multi-cultural, global-minded environment, in a company that values and praises professional growth and career advancement.
- Applying the knowledge and experience of QA in multidisciplinary teams, taking always the patient well-being as the core value.
- Good salary package.