TS Validation Specialist
Pfizer Canada Inc.
HsinChu, Taiwan
20小时前

Responsible for process robustness and related data collection / analysis and trial studies to meet site objectives and quality compliance.

TS Routine in process control data and process parameter collection and analysis to ensure process robustness and identify process improvement opportunities.

Current practice is manual record, will also digitalize the record for future analysis.

收集生產製程相關訊息 數據資料分析 協調測試研究活動 以確定有效解決方案與持續改善機會

Responsible for TS documentation and filing system. Create and revise assigned documents to meet GMP, regulatory and quality requirements.

Follow up the assigned actions, feedback actively and consistently delivering result in good quality. Will also support TS routine work.

部門文件管理及歸檔作業 指定文件改版以符合法規與品質要求 主動回報工作進度 與支援例行確效作業

學經歷要求

At least 2 year experience in Pharmaceutical related filed. Fully understanding of GMP, pharmaceutical manufacture process and validation program.

Technical service, Research development, Production field experience is plus.

1.至少2年製藥相關工作經驗 了解GMP 製藥過程和確效驗證程序 技術服務 研發 生產現場經驗者優先

A highly motivated, results-oriented, self-starter who demonstrates personal accountability for outcomes and thrives on increasing levels of responsibility.

2.積極主動 並表現出對成果的個人責任感

Problem solving skills (problem identification, analysis, creativity, application of corrective action)

3.解決問題的能力 問題識別 分析 創造力 改善措施的應用

Interpersonal skills that are compatible in an environment of teamwork

4.良好人際關係技巧及團隊合作

Good communication, writing and presentation ability. English is plus.

5.良好的溝通 寫作和表達能力.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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