副總監(jiān)-GMP支持負責人

2.5-4萬·15薪

無錫新吳區(qū)
10年以上
本科
全職
招1人

職位描述

GMP認證

Job Summary?
The GMP Support Lead is a key technical and leadership role within the Drug Product Manufacturing Science & Technology (MSAT) team. This position ensures compliance with Good Manufacturing Practices (GMP) and regulatory requirements while driving continuous improvement in manufacturing processes, quality systems, and operational excellence. The role involves collaborating with cross-functional teams (e.g., Quality, Engineering, Operations, Regulatory Affairs) to support product launches, troubleshoot manufacturing issues, and implement innovative solutions.

Key Responsibilities:
? Provide technical support for manufacturing operations, ensuring adherence to GMP and regulatory requirements (e.g., FDA, EMA, NMPA).
? Collaborate with cross teams to optimize production processes, troubleshoot deviations, implement corrective actions, and initiate change control.
? Lead sterility assurance activities, including smoke study, and aseptic process simulation, etc.
? Support external regulatory inspections (e.g., FDA, EMA) by preparing audit responses and facilitating communication.
? Work closely with Quality, Production, and Engineering teams to address GMP-related issues and streamline workflows.
? Participate in risk assessments (e.g., FMEA) and contribute to continuous improvement initiatives for GMP compliance.
Requirements:
? Bachelor’s degree or above in Pharmacy, Biotechnology, or related field; familiarity with GMP guidelines. No less than 10 years related working experience with fluent English.
? Strong analytical skills and attention to detail in documentation review and audit preparation.
? Ability to communicate effectively in cross-functional settings and adapt to dynamic regulatory environments.

職位概述
GMP 支持主管是藥品生產(chǎn)制造科學與技術(shù)（MSAT）團隊中的關(guān)鍵技術(shù)和領(lǐng)導(dǎo)角色。該職位確保符合良好生產(chǎn)規(guī)范（GMP）和監(jiān)管要求，同時推動制造流程、質(zhì)量體系和運營卓越的持續(xù)改進。此角色需要與跨職能團隊（例如質(zhì)量、工程、運營、法規(guī)事務(wù)）合作，支持產(chǎn)品上市、解決制造問題并實施創(chuàng)新解決方案。
主要職責：
- 為生產(chǎn)操作提供技術(shù)支持，確保符合 GMP 及監(jiān)管要求（例如，美國食品藥品監(jiān)督管理局、歐洲藥品管理局、國家藥品監(jiān)督管理局）。
- 與跨部門團隊合作，優(yōu)化生產(chǎn)流程，解決偏差問題，實施糾正措施，并啟動變更控制。
- 主導(dǎo)無菌保證活動，包括煙霧研究和無菌工藝模擬等。
- 通過準備審核回復(fù)和促進溝通，支持外部監(jiān)管檢查（例如，美國食品藥品監(jiān)督管理局、歐洲藥品管理局）。
- 與質(zhì)量、生產(chǎn)和工程團隊密切合作，解決與 GMP 相關(guān)的問題，并優(yōu)化工作流程。
- 參與風險評估（例如，失效模式與影響分析），并為持續(xù)改進 GMP 合規(guī)性的工作做出貢獻。

要求：
? 藥學、生物技術(shù)或相關(guān)專業(yè)本科及以上學歷；熟悉 GMP 指南。具有不少于 10 年相關(guān)工作經(jīng)驗，英語流利。
? 具備出色的分析能力和細致的文檔審查及審計準備能力。
? 能夠在跨職能環(huán)境中有效溝通，并適應(yīng)動態(tài)的監(jiān)管環(huán)境。