|This posting is managed by:||
RecruiterMichael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社
|Company Name||Company is not publicly visible|
Medical/Pharmaceutical/Bio/Fabric/Food - QA/QC
This position mainly responsibility is to handle complaints from initiation to close-out, both for medicinal product and medical device, batch record review for secondary packaging and full documentation to support Japan market release. Additionally, the correct documentation of deviations & CAPAs is needed to support products in Japan, as well as keeping the monthly quality metrics.
* 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.
To apply online please click the 'Apply' button below.
For a confidential discussion about this role please contact Eduardo Takara on +813 6832 8678.
|Company Info||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.|
|English Level||Business Conversation Level (TOEIC 735-860)|
|Japanese Level||Fluent(JLPT Level 1 or N1)|
|Salary||JPY - Japanese Yen JPY 6000K - JPY 8000K|
Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社