職位描述：
Principal Accountabilities: Develops and implements validation master plans and policies. Oversees and reviews validation area processes and procedures. Make recommendations for changes and improvements. Leads validation projects by scheduling, resource allocating, and project deliverables. Manages large capital and technically complex projects on equipments or processes that includes authoring protocols, executing validation, and writing reports. Provides technical leadership on cross-functional investigation teams, which includes exploring new techniques, methods, and other industry practices. Assists in writing regulatory filings and represents validation in regulatory audits/inspections. Reviews and approves work performed by internal staffs or outside consultants. Basic Function: Develops validation strategies, policies, plans, procedures, and project requirements. Independently plans, performs and documents commissioning and validation activities (DQ, IQ, OQ, PQ) for equipment, facilities, and utilities in a parenteral drug manufacturing environment. Leads the validation activities for large capital projects. Tracks and communicates progress of work against milestones. Supports regulatory submissions and audits. Requirements: BS or MS degree in chemical, biological, mechanical engineering or related sciences 7+ years industry experience in finished dosage parenteral pharmaceutical validation or quality engineering/assurance Experience in validation of aseptic operations. In depth knowledge of current FDA GMP regulations and FDA trends and guidelines Experience with computer/software validation Strong leadership, communication, organization and time management skills Ability to read, write, and speak English

企業介紹:

　　迪醫獵頭（www.otkrivenozdravlje.com）于2003年成立，由幾個海外歸來的獵頭顧問創建，我們服務于藥品、醫療器械、醫院管理，保健品，還有生物工程，專業專注于醫藥衛生行業是我們的目標，我們的團隊成員由多位經驗豐富的具有醫藥醫療企業背景的獵頭顧問組建而成，主要為國際（內）醫藥企業提供中、高級人才尋訪，即獵頭服務。

　　我們的獵頭顧問均會依靠個人的“能力”、“經驗”、“努力”完成任務，我們關注職位成功率和職位完成時間，我們的目標是：“90%職位成功率”和“1-2周之內完成待聘職位初次推薦”。

　　迪醫獵頭總部位于北京，并通過設在各地的合作伙伴及網絡，提供完善的獵頭服務，因為專業和專注，有效提高了工作效率，降低了過程成本，從而間接降低客戶成本。因為事先關注成本，所以我們向客戶進行收費時，通常按行內最低標準進行收取，盡可能保證客戶的利益。

　　迪醫獵頭，專業醫藥人才資源服務機構。我們吸引了成功的醫藥獵頭顧問，我們擁有高端行業和高端職能崗位相關的專業技術，醫藥獵頭顧問的出眾才智改進您的招聘程序，并且使您的公司更好地了解市場和競爭狀況。

　　迪醫獵頭致力于招募全球最優秀的醫藥高級人才，為優秀的企業提供最合適的醫藥人才，品質成就品牌，迪醫獵頭專業醫藥獵頭全力打造醫藥界高端人才的供需平臺！