雇員點評標簽
職位描述
QA
崗位職責:
Primary Responsibilities and Accountabilities:
1.Independently conduct project audits (e.g., protocols, data, reports, etc.) and facility inspections, identify nonconformities, assess associated compliance risks, and prepare detailed QA audit reports.
2.Manage and oversee quality issues, deviations, and CAPAs, ensuring all actions are effectively and promptly addressed, tracked, and closed.
3.Facilitate discussions with team members and escalate any nonconformities or critical quality issues to laboratory and senior management.
4.Support sponsor audits and regulatory inspections as the primary QA liaison, coordinating between internal stakeholders and external auditors, and ensuring timely and comprehensive responses with follow-up on action items.
5.Review and approve internal SOPs, ensuring alignment with regulatory requirements, and collaborate with the Compliance team to monitor and enhance overall compliance.
6.Oversee and participate in the lifecycle management of computer system validation (CSV) to maintain systems in a validated state throughout their operational lifecycle.
7.Continuously identify and assess potential risk areas, communicate findings to management, and propose and implement risk mitigation strategies.
8.Develop and deliver training programs for internal stakeholders to enhance quality awareness and compliance with quality standards.
9.Collect and analyze the latest regulatory and industry developments, ensuring the company
s quality systems remain up-to-date and aligned with current standards.
10.Lead and promote quality improvement initiatives and projects to enhance R&D operational efficiency and overall research quality.
11.Perform additional quality assurance tasks as assigned by management.
任職要求:
Qualifications:
1.Education: MS or BA in pharmacy, biology, or a related discipline, or an equivalent combination of education, training, and experience.
2.Experience: Minimum of 3 years’ experience in the pharmaceutical or biotechnology industry, preferably in Laboratory Quality Assurance or a related technical role.
3.Knowledge and Skills:
a)Understanding and practical expertise in GxP regulations (GLP etc.) is preferred.
b)Proven knowledge of drug development processes, R&D laboratory operations, and quality management principles.
c)Excellent written and verbal communication skills, with the ability to work collaboratively across departments and levels of the organization.
d)Strong organizational and analytical skills, with a proactive and detail-oriented approach.
e)Ability to manage multiple priorities effectively while maintaining high quality standards.
工作地點
浦東新區中國上海外高橋自貿區富特中路288號
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職位發布者
劉先生/資深人力資源
昨日活躍立即溝通
藥明康德新藥開發有限公司藥明康德（股票代碼：603259.SH/2359.HK）為全球醫藥及生命科學行業提供一體化、端到端的新藥研發和生產服務，在亞洲、歐洲、北美等地均設有運營基地。藥明康德通過獨特的“CRDMO”業務模式，不斷降低研發門檻，助力客戶提升研發效率，為患者帶來更多突破性的治療方案，服務范圍涵蓋化學藥研發和生產、生物學研究、臨床前測試和臨床試驗研究等領域。2024年，藥明康德連續第四年被MSCI評為ESG（環境、社會及管治）AA級。目前，公司的賦能平臺正承載著來自全球30多個國家約6,000家合作伙伴的研發創新項目，致力于將更多新藥、好藥帶給全球病患，早日實現“讓天下沒有難做的藥，難治的病”的愿景。
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