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新着求人 品質保証  (FA-14)
募集職種 外資系製薬企業の クオリティアシュアランス シニアスペシャリスト
勤務地 東京
会社概要 非公開
求人要件 【職務内容】
Senior Specialist, Therapeutic Area (TA) Quality, MRL Quality Assurance (QA)
Essential functions include but are not limited to: in partnership with the Quality Assurance Lead (QAL) and/or a tenured Quality Assurance Specialist, the Quality Assurance Specialist (QAS) will support the implementation of the Quality Assurance strategy across multiple studies and/or countries. The QAS will utilize audit and inspection intelligence and risk mitigation plans to assure adherence to Good Clinical Practice (GCP) Regulations in conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of study participants. The QAS position is responsible for the execution of the global Quality Assurance audit activities on assigned studies/products/vendors/Country Offices. This role is responsible for GCP oversight and for assuring the compliance of studies with Merck Standard Operating Procedures (SOPs), Policies and all applicable worldwide regulations and guidelines (e.g., US FDA, EU Directives, ICH and National regulations).
BS/BA degree in relevant area with commensurate experience in field.
Minimum of 5 years pharmaceutical or related industry experience, including work related to clinical trials and/or GCP business quality
Advanced knowledge of J-GCP/ICH-GCP and related regulations/guidelines
Ability to travel both internal and external Japan
Communication Skills both in Japanese and in English: Demonstrates effective communication skills to convey and receive information. Demonstrates effective oral and written communication skills
Collaboration and Partnering: Effectively partners with others (within MRL QA and external to MRL QA) to accomplish quality goals; possesses group leadership skills.
Business Operations/Knowledge of Field: Effectively applies knowledge of regulations and business trends and applies this knowledge to optimize daily activities and collaborates with MRL QA management to make appropriate decisions that improves the quality of business and functional area outputs.
Regulatory and Compliance Management:Effectively applies knowledge of regulations and regulatory trends in consult with MRL QA management to ensure MRL QA and appropriate functional areas within MRL are compliant with regulations and appropriate procedures.
Preferred Experience and Skills:Prior GXP audit experience
Knowledge of IT system validation, Good Pharmacovigilance Practice (GPVP) or other GXP regulations/guidelines
待遇 :650万~1100万程度想定(前職考慮)
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