キャリアクロス外資系求人サイト : バイリンガル向けの求人情報を毎日更新！外資系企業をめざすならキャリアクロス。 http://www.careercross.com/913112.xml Mon, 07 Jul 2008 09:24:12 +0900 CareerCross - Report to Head of Quality Assurance - Plan audit schedule for clinical trials. - Conduct audit (for healthcare providers, CROs, internal process 　　and documents) - Conduct training and consultation for non-QA departments. - Review SOP, WI and checklists related to QA. http://www.careercross.com/0099048.html Wed, 02 Jul 2008 11:40:00 +0900 ・海外製造部品を日本の顧客に納品する際の品質保証/品質管理業務。海外工場と顧客との　コミュニケーションや不良品対応などを含む。 http://www.careercross.com/0077833.html Mon, 30 Jun 2008 23:48:00 +0900 仕事内容///////////// ISO 13485、EC指令（93/42/EEC、90/385/EEC、98/79/EC)、米国要求事項または薬事法等、医療機器および体外診断用医薬品関連の審査・認証業務。 会社概要/////////// ドイツ系技術検査協会の日本法人で、125年以上の歴史を有するヨーロッパ最大級の公認機関のひとつです（世界拠点は300を超え、主要都市はほぼすべて網羅しております）。日本国内においても約100の民間ISO認証機関のうちトップ5に入る実績を持ちます。 世界に広がる各拠点には約8500名の社員が活動しており、年間売上高は7.3億ユーロです。50カ国以上に 80を越える子会社を有しており、したがって、ドイツ国外においても技術管理会社のトップに位置しています。世界に広がるネットワークで、お客様に納得のいくオールインワンのサービスを提供しています。 130年間に培われた伝統と実績で、インダストリアルエンジニアリングサービス、自動車・運輸、製品安全及び品質、教育コンサルティング、ITサービス・新技術の5つの分野で特に力をいれています。 http://www.careercross.com/0075588.html Sun, 29 Jun 2008 14:35:00 +0900 ・品質システムセクションのマネジメント全般 ・輸入製品(出荷前製品)の検品 ・品質システムの構築、メンテナンス(ＣＡＰＡ、ドキュメントコントロール、サプライヤー管理、監査) ・コンプライナンス管理(ＰＡＬ、ＧＭＰ、ＱＭＳ、ＧＱＰなど) ・医薬品や医療機器の品質管理、品質保証 ・ＧＭＰ、ＱＭＳ、ＧＱＰドキュメントの作成、メンテナンス http://www.careercross.com/0099443.html Tue, 24 Jun 2008 09:51:00 +0900 Our client, a global pharmaceutical and chemical company is seeking a Clinical Quality Manager for their Tokyo branch. The Clinical Quality Manager will be responsible for promotion and management of compliance with clinical studies GCP of drug medicine and SOP of the company in Japan. QC work ・ Manage and operate work so that clinical studies meet the regulatory requirements such as GCP etc. ・ Initiate to avoid deviation of ongoing clinical studies after reviewing audit reports ・ Revise documents such as clinical trial protocols, study report and application documents (CTD) etc from the overall consistency point of view SOP creation work ・ Create company policy/system and SOP (related to clinical development) to meet the regulatory requirements such as GCP Educational Training work ・ Operate and monitor training of regulatory requirements such as GCP ・ Operate and monitor medical and professional trainings CRO management work ・ Select a trustee of development work (CRO) and conduct contractual transactions communicating with HW regarding clinical studies related work ・ Monitor the selected CRO and train appropriately when necessary ・ Clinical trials management work ・ Monitor and maintain the storage of the clinical trials have the clinical trials which meet the storage requirements ・ Insure all the clinical trials meet storage requirements http://www.careercross.com/0082376.html Mon, 23 Jun 2008 12:55:00 +0900 Use your Regulatory Affairs or Clinical Development experience to help this company revitalize their RA division. You will be responsible for: Oversight of 2 junior RA personnel Product application submission process Interaction with PMDA officials to insure timely application approval process Work with Marketing Department on product launch timetables Evaluation and improvement of current RA system within the company Translation of English documents into Japanese http://www.careercross.com/0098929.html Tue, 17 Jun 2008 17:05:00 +0900 The position of pharmacovigilence manager or safety controller will be involved with all GVP duties. The position will involve: - gathering, analysing and disseminating safety related information (adverse events etc) - Use of specialised and dedicated proprietary software for managing confidential information - Submission of materials as well as regular negotiations with regulatory authorities. - Assessment and compliance related duties for promotion material and packaging. http://www.careercross.com/0077658.html Fri, 13 Jun 2008 15:53:00 +0900 Clinical Quality Assurance Manager Opportunity You will report to the head of the global quality assurance department and will manage all quality assurance issues to ensure that processes, procedures and activities are in compliance with GCP and other regulations in Japan. You will investigate and resolve compliance problems and questions regarding Regulatory Affairs, Clinical Operations, Data Management and Biostatics. Benefits Opportunity for foreign travel Career opportunity to take on a role outside of Japan in other office locations globally Self-development and education/training programs Opportunity to build a new function within the company http://www.careercross.com/0068162.html Thu, 05 Jun 2008 17:45:00 +0900 MAIN RESPONSIBILITIES : Create, implement and maintain complaint handling systems, ensuring accuracy in report data as well as trend analysis Support regulatory compliance and optimize quality system procedures relating to product complaint handling Put in place guidelines and proactively steer team to comply to PAL, GMP, GQP and the Global Quality System Provide key knowledge as a resource and support the development, implementation and maintenance of complaint handling processes, quality metrics etc. to drive improvement in complaint handling Work closely with, and communicate with key managers, in the R&D, Sales & Marketing, Manufacturing, SCM etc. to provide complaint data to further push for higher productivity, and high product quality Put in place tracking metrics and lead team in strategizing and driving processes for increasing productivity levels in current complaint handling procedures and processes Coach team and drive change initiative across the board to push for complete adherence to quality issues Build growth oriented environment and steer team towards achieving quality targets Identify key personnel to invest and further develop http://www.careercross.com/0051968.html Thu, 05 Jun 2008 17:45:00 +0900 Quality Control Manager General Summary: The objective to have new QC manger is to strengthen organization for corresponding to US HQ requirements, while sustain the alignment with Japan unique (PAL) regulations. In summary they are looking for someone who will be able to work by himself/ herself according to high level directions. Because the interactions with the US/ EU will be key the person needs to understand foreign culture or needs to be flexible enough to be able to interact with US / EU teams. This should be a very interesting position for someone ready to face challenges. It will be very visible position, because of the importance of the work that needs to be implemented and because of the expectations from the company. Other general QC activities: ・Judgment for product shipment ・Comply with GMP for documents ・Technical support inspection line ・Feed back quality to manufacturer Minimum Education & Experience: Bachelor’s-level degree required. ・Quality Engineer ・Manufacturing Engineer ・Quality improvement ・Expert knowledge GMP, QMS http://www.careercross.com/0092524.html Mon, 19 May 2008 14:03:00 +0900