manager/ specialist quality assurance.

Responsibilities (include but are not limited to):•Act as back up for Quality Assurance Manager (Hinseki) •Collaborate with cross-functional departments to ensure timely implementation of quality processes•Release of Cell Therapy Finished Products in Japan and Quality monitoring of importation of Cell Therapy Finished Products in Japan when applicable•Maintain Standard Operating Procedures (SOPs) to ensure quality objectives are met.•Provides QA oversight and approves deviations, change controls and product complaints investigations for the manufacture, packaging and shipping events impacting Cell Therapy Products for Japan when applicable•Provides necessary information and reports to GQP QA for awareness or approvals to meet regulatory requirements and internal procedures when applicable•Works on routine QA operations such as Release, Change Control, Deviation, Product Complaint, Quality Documents creation and revision, training• Oversee Japan CMO for validation/qualification activities and manufacturing, quality controls.•Maintain metrics related to Quality of Commercial Cell Therapy Product(s)•Assist to prepare and make a response for GCPT inspection by PMDA•Work with Regional and Corporate (Quality) teams, as needed•Work with the Site Qualification team to ensure Cell Therapy related local requirements are met•Perform other duties as assigned

求められる経験
Requirements:

• Bachelor’s degree in medical technology, biological sciences or related field; Master’s degree preferred
• Minimum of 5 years progressive experience in medical, pharmaceutical or biologics quality systems’ roles
•Experience with product import lot disposition, deviation and change control management preferred
•Proficiency in English and Japanese
•Strong working knowledge of and ability to apply cGMP/GCPT/GQP principles in conformance to Japanese standards
•Broad experience across areas like Quality Assurance and/or Quality Systems and understanding of parenteral and aseptic operations is beneficial
•Comfortable interacting with regulatory agencies as needed
•Proficient in MS Word, Excel, and Power Point
•Demonstrated ability to develop, coach, and mentor employees
•Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
•Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
•Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description

保険
健康保険　厚生年金保険　雇用保険

休日休暇
土曜日　日曜日　祝日

給与
年収800 ～ 1,200万円

賞与
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