会社概要
Global Pharmaceutical company with a long tradition in Japan. My client is looking for ambitious, proactive professionals looking to make a change.
2012年4月22日日曜日
Global QA At Top Level Pharmaceutical Company 求人 関西地方 | 品質管理・品質保証転職情報
職務内容
- Conduct independent appraisals of quality and compliance systems within technically advanced manufacturing settings.
- Performs complex and demanding domestic, regional and international (subject to experience) audits of suppliers of chemicals, packaging components, and finished drug products, or contracted services. Audits are conducted in accordance with cGMP's, ISO Standards, IPEC, ICH Q7A and company procedures.疲労シンポジウム
- Plans, coordinates and conducts scheduled or unscheduled cGMP audits of complex internal Company Operational departments to ensure compliance to cGMP's and Company standards.
- Provide clear and scientifically/technically justified interpretations and support for any audit findings and proposed corrective and preventive actions.
- Liaise directly with local and/or regional and global senior management, where necessary, to ensure issues are understood and proposed actions are acceptable.
- Interpret and apply CGMP regulations and expectations.
- Proven written and oral skills with experience working in cross-cultural settings
- Initiate and maintain close contacts with regulatory agencies and/or industry/professional organizations to keep aware of trends and initiatives in quality assurance, GMP compliance, and inspections.データ復旧サービス株式会社フォールズチャーチ
- Develop and interpret audit findings across the scope of the Worldwide GMP Audit Group in order to communicate trends and provide recommendations to address such developing trends in a proactive manner.
応募条件
- Solid knowledge of modern quality systems, risk assessment, corrective and preventive action development and execution, and other evolving principles across the global compliance arena.
- Bachelors degree in a scientific discipline
- Ability to travel extensively (up to 60% of time local/regional/global)
ドバイのトップ10広告会社
活かせる経験
- 10 years experience in a QA environment with increasingly responsible job requirements including audit experience
- Overseas auditing experience particularly in Europe or the US
- Experience in other GXP areas (GLP,GCP)
求める人物像
- Cross-cultural awareness and sensitivity
- Self-directed and highly motivated team player with solid organizational capabilities
待遇・福利厚生
Social, Health insurance, transportation, Retirement
休日・休暇: All Japanese national holidays, summer winter+ paid holidays
その他
Global QA at Top Level Pharmaceutical Company
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