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GMP Quality Senior Compliance Expert Manager

年収:800万 ~ 1000万

ヘッドハンター案件

部署・役職名 GMP Quality Senior Compliance Expert Manager
職種
業種
勤務地
仕事内容 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
応募資格

【必須(MUST)】

- Experience in a regulated industry is required; cosmetic and 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


更新日 2021/02/04
求人番号 1530386

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