【外資大手製薬企業】GQP/QMS シニアアソシエイト

Responsibilities will include, but are not limited to the following:

• Ensure accurate and thorough compalint intake information, replacement need, troubleshooting with compainant, complainant follow- ups, product complaint investigations. trachking and trending of complaint data. Accurate reporting into the internal software system/QMS system, follow-up, communication to complaints, identification of trends, assisting with determining CAPA's
• Review each compaint assigned for accurate/missing information, comoplaint details further regulatory complaince 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, trouble shooting, and medical device replacement and returns
• Perform complaint investigations to determine root cause, identify resolution and respond to the complainants
• Issue complaint close-out notifications to complainants.
• Ensure Adverse Events reported through the complaint system or at patient follow-up are reported within one business day
• Ensure the reconciliation between the complaints report and Safety/Customer reports
• Support product/supplier changes, deviations and CAPAs, assisting with technical write up, impact assessment, and root cause analysis.
• Assist in maintaining the applicable GQP and QMS SOPs. • Check quality progress on a monthly basis as they relate to batch release, complaints, deviations, CAPAs’, change requests or other relevant quality metrics. Powered by Purpose
• Asist internal process audits and external supplier audits as necessary.
• Actively work on Global and local Quality projects
• Support 3 officer activities and authority inspection

Experience/Knowledge/Skills

• Minimum 3 years’ experience in a similar role within pharmaceutical or medical device industry
• Thorough knowledge of GMP, GQP and good documentation practice
• Experience in quality related complaint handling is preferred • Experience in working with an electronic Quality Management system is desired.
• Must have excellent communication skills (verbal and written).
• Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter.
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Works effectively across functions as a team player
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• An uncompromising ethical standard and level of conduct are essential

Qualification/Certificate

• Bachelor’s degree in life sciences or equivalent through experience

Other

• Must successfully exhibit Insmed’s five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect and Integrity; along with any other position specific competencies
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace
• Non-smoker
• Travel up to 10% (domestic and international), some of which will be overnight in nature