求人番号40036 会社名外資製薬メーカー 業種製薬 職種分類生産管理 / 品質保証 ＧＭＰ ポジションQuality Partner Japan 仕事内容 JOB SUMMARY
The goal of this function as the primary Quality contact is to ensure global quality practices are integrated in the region to ensure compliance and safety obligations are met with regard to local regulations.
This position is responsible for the maintenance of the GxP status of the affiliate in accordance with national and international GMP and legal requirements.
Release of products according to the requirements including final evaluation of deviations with regard to their impact on the pharmaceutical quality of drugs.
Deliver best in class service and ensure implementation maintenance and upgrading of the local Quality System in order to drive compliance of all relevant cGXP with local / International regulatory requirements and our global standard operating procedures
Lead and coordinate periodic Management Review of Quality Systems
Ensure efficient information flow and effective communication of all relevant quality matters within the relevant Affiliate organization from the Territory to the Global Quality organization and vice-
versa including but not limited to issue escalation and communication of new regulations Ensure that co-ordinated contact is maintained with the local Regulatory Authorities and the local partners (suppliers third parties licensees and distributors) and Interface with authorities in collaboration with RA as appropriate
Ensure Affiliate readiness for all GxP regulatory inspections and management of those inspections.
Ensure that adequate input is provided through the relevant quality plan and budget process to make sure adequate quality resources are available.
Ensure that appropriate quality management of local Partners / Vendors / 3PLs to the External Network Governance (ENG) guidance (qualification quality agreements vendor management divestment) and Manage QA activities associated with Global partnerships where agreed
Ensure all Quality deliverables are completed in a timely manner in accordance with Corporate QMS (e.g. follow up and closure on all relevant complaints deviations and CAPAs change controls)
Support Global projects on quality systems as needed.
Maintain list of all local licenses and certificates in collaboration with RA
応募条件 Bachelor's Degree
Minimum of 10 years working in the pharmaceutical industry in a quality management position. Operational GMP experience would be a distinct advantage.
Experience interacting with regulatory bodies and third party organisations with respect to QA systems and regulatory inspection
Auditing expertise would be a distinct advantage.
Must be skilled and experienced in operating in a multi-cultural environment
求める人物像 Ability to work with high level of autonomy and handle complex / difficult situations. Output from actions will most likely impact activities across several departments.
Must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product and quality related matters.
Self-motivated team player who can encourage and support new ideas and act as a role model for others in driving the departmental / company vision.
Be able to coach / train / mentor colleagues as well as deliver training within area of expertise and assist with the development of top talent 必要スキル Solid knowledge of relevant legal requirements of the global pharmaceutical industry including the interpretation and practical application of applicable regulations.
Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
Possess auditing capabilities and skills.
Management skills + Project management skills
Must possess excellent interpersonal verbal and written communication skills at all levels internally and externally especially at senior management level.
Must possess root cause and risk management / assessment skills
English Business level
年収 800万 1100万 雇用形態正社員 勤務地東京本社 勤務時間9 00 17 30 フレックスタイム制 コアタイム無し 昼休み1時間 福利厚生退職年金 団体生命保険 定期健診 各種社会保険 財形財蓄制度 永年勤続表彰 クラブ活動 英語学習補助 休日休暇週休2日制 土 日 祝日 夏季休暇 年末年始休暇 有給休暇 慶弔休暇 特別休暇 募集背景戦力強化のため 担当者脇 裕美子 担当メッセージバイオ医薬品に特化している外資製薬会社でQuality Partner 職を募集いたします