仕事概要
職種 | 営業、事務、企画、物流系/物流管理、貿易手続き、調達、バイヤー、店舗開発 |
---|---|
業種 | 消費財/ 化粧品 |
雇用形態 | 未分類 |
ポジションレベル | その他 |
募集人数 | 1名 |
希望入社時期 | - |
必須語学力 |
英語 (流暢に話せるレベル) 日本語 (流暢に話せるレベル) |
活かせる語学 | - |
勤務時間 | その他 |
福利厚生・休暇 | |
ビザ取得支援 | - |
外国人従業員 | - |
仕事詳細
Company Overview
Leading Global Company
Job Description
Senior GMP Quality Compliance Expert - Manager Level
Requirements
More than 5 years’ experience in a GMP, high paced manufacturing environment
Experience in a regulated industry is required; cosmetic and/ or pharmaceutical experience a plus Experience with improving Quality Systems and process design is required
Experience with authorizing and maintaining procedures and work instructions is required
Knowledge of compliance, related to all applicable Quality Systems Standards national and international, is required Ability to build and deliver training modules
Creative individual with excellent trouble shooting skills
Strong oral and written communication skills with ability to appropriately communicate information to cross functional stakeholders
Ability to work in a team setting and independently under minimal supervision
Ability to work in fast paced environment supporting the quality assurance/quality control departments Proficiency in Microsoft Office Suite, Electronic QMS, e-training systems and SAP systems is preferred
Education: Bachelor’s science degree or equivalent experience
Language: Good command in Japanese and English, both written and spoken
Additional Job Information
Position Summary:
Compliance Specialist is responsible for implementing policies, procedures and standards at a site to ensure compliance with regulatory and corporate requirements. This includes management of GMP document control systems, development of annual product review reports, administration of the compliant program, supporting site audits and development & delivery of GMP trainings.
Key Responsibilities:
Policies, Procedures and Standards (40%)
Implement and enforce policies, procedures and standards
Conduct internal site audits, document audit results and ensure site audit preparedness
Maintain knowledge and understanding of applicable GMP regulations, regulatory agency guidelines, industry association guidelines and good practices
Manage complaint program and monitoring for trends, coordinate requirements of investigation from site when required
Manage annual product review reporting which includes compiling data for reports and completion of each report (adhering to schedule for APR Execution)
Document Control Systems (30%)
Site owner and subject matter expert for the management of GMP documentation, change control and CAPA systems
Manage the document change control processes that involve the receipt, maintenance, approval, distribution, maintenance of files and storage of documents to include, but not limited to: batch records, standard operating procedures, protocols, deviations, investigations and standard forms.
Training/Coaching (30%)
Develop and implement a standardized training process that complies with all regulatory/corporate requirements (GMP focus) by working with site functional leads, Quality CoE Training & Capabilities Manager, Corporate QA, and training peers to develop processes, tools and templates to deliver a standardized approach
Establish training curriculum and assignments based on assigned functions in collaboration with site leadership and Quality CoE Training & Capabilities Manager
Develop and deliver site level GMP training for new employees and re-fresher trainings as required Develop, maintain and report appropriate training metrics
面接について
連絡先
Quality Senior Compliance Specialist - Lvl 10
RGFタレントソリューションズ株式会社
800 〜 1000 万円