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生産物流本部、 富士工場、 品質部門、 品質コンプライアンス、 シニア コンプライアンス スペシャリスト
年収：800万 ～ 1200万
採用企業案件
ヤンセンファーマ株式会社
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- 会社規模501-5000人
- 医薬品メーカー
| 部署・役職名 | 生産物流本部、 富士工場、 品質部門、 品質コンプライアンス、 シニア コンプライアンス スペシャリスト |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in pharmaceutical, and medical devices markets and have the skills and resources to tackle the world's most pressing health issues. The Innovative Medicines Regulatory Compliance organization is recruiting for a Senior Compliance Specialist. This position will be based in the Fuji site, Japan. ■DESCRIPTION The Senior Compliance Specialist reports directly to the Director, J&J Regulatory Compliance (Japan). This position will execute the internal audit program at the Fuji site, prepare and manage external GMP audits and inspections (e.g. Health Authority, Customer, ERC, etc.), provide compliance subject matter expertise to the manufacturing site and site-based projects, deploy compliance initiatives for the site in alignment with Innovative Medicines Regulatory Compliance. RESPONSIBILITIES •Execute internal audits (schedule, issue agenda, prepare, conduct audit, issue report) • Execute compliance walk-throughs (e.g. GEMBA) • Evaluate responses to internal audits • Enter internal audit data into COMET • Enter GEMBA findings into the appropriate database •Facilitate and/or support external GMP audits and inspections (Health Authority, Customer). Including: • Inspection Readiness (audit preparation, schedule and manage mock inspections, SME • coaching) • Partner with Quality to manage inspections (host and/or coordinate front room and back • room, daily inspection summaries) • Review site response and associated CAPA for Health Authority inspections. • Provide input to daily inspection summaries, as needed. •Identify changes in regulations that impact compliance procedure, perform gap analysis against current practices. Implement J&J Compliance Standards (e.g. Audit/Inspection Management) and partner with sites on J&J standard implementation. • Provide Compliance Subject Matter Expertise (SME) for site personnel, Quality Systems and/or projects. As needed, review complaints and field actions. • Represent Regulatory Compliance at Site Management Reviews, CAPA Review Boards, Escalations, Platform Compliance meetings, etc. • Partner with site for execution of proactive compliance scans. • Partner with site and segment personnel (e.g. Regulatory Affairs, Operations, Product Quality Management, etc.) to proactively identify risks and drive compliance improvement across the site. • As applicable, monitor progress of site compliance remediation plans (e.g. MCAP, SDCAP, etc.) • Collaborate with other groups in IMRC and JJRC to support execution of independent audits and special investigations. Support site during ERC audits (e.g. document review, front/back-room support). Review and provide input to site response, and associated CAPA, to ERC audits. • Ensure timely and accurate reporting of compliance metrics. • Lead the Inspection Readiness Governance meetings. • Coordinate compliance training for the site. • Connect with external groups (e.g. Japan Manufacturers Association etc.) to benchmark industry standards. • As needed, co-authors, review, and revise compliance procedures. • As needed, review (not approve) significant manufacturing and laboratory investigations, confirmed complaints and S1/S2 Field Actions. |
| 応募資格 |
【必須（MUST）】 • Bachelor’s degree in science or related field is required.• Minimum of five (5) years of experience in GMP-regulated industry and at least one (1) year of regulatory compliance experience is required. • Strong knowledge of global GMP regulations is required. • Strong analytical skills. Ability to clearly articulate issues. • Must have excellent communication skills, able to quickly build credibility within the Quality and Compliance community. • Delivers on commitment timelines and has high sense of urgency. • Experience preparing for inspections, managing inspections and/or supporting inspections. • QA/RA certification is preferred. • Experience performing internal or external audits is strongly preferred. • Experience in change management and project management. • Ability to communicate in both Japanese and English is strongly preferred. LOCATION •This position will be based in Fuji site Japan and may require up to 15% domestic. |
| リモートワーク | 不可 |
| 受動喫煙対策 | その他 「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください |
| 更新日 | 2024/12/10 |
| 求人番号 | 3782299 |
採用企業情報
- ヤンセンファーマ株式会社
-
- 会社規模501-5000人
- 医薬品メーカー
-
会社概要
私たちヤンセンファーマは、世界最大級のトータル・ヘルスケア・カンパニー、
ジョンソン・エンド・ジョンソン（J＆J）グループの製薬会社として、いまだ
満たされていない医療ニーズに迅速に応え、最先端の医薬品を一刻も早く患者
さんの手元に届けることができるよう取り組んでいます。
私たちは、世界57ケ国200社以上に及ぶJ＆Jグループを貫く経営理念「我が信条
（Our Credo）」を志とし、さらに、46年間に84品目もの新薬を開発したヤンセ
ン・ファーマスーティカ社の創業者、ポール・ヤンセン博士の妥協なき開発精
神を継承し、J＆Jグループの優れた新薬の導入はもちろん、医療現場への適切
かつ最新の医療情報の提供、さらには、患者さんのＱＯＬ（クオリティ・オブ・
ライフ）の向上を目指した支援活動などをおこなっています。
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です