锦鲤求职岗位描述
职责 Responsibilities：
1. As a Sr. Quality Manager, you will be responsible for implementing quality oversight for GMP activities within Asieris to ensure that Asieris internal and external providers of critical services (CMOs) comply with Asieris data integrity and quality standards, GxP regulations and meet nation health authority requirements.
2. Maintain and improve quality system within Asieris.
Risk Management: Support and assist in risk areas identification, escalation, and mitigation plan development.
Ensure efforts are implemented effectively and in line with quality goals, strategy, and objectives.
3. Promote and implement a Quality culture within Asieris.
Manage quality meetings (timeframe to be defined) according to a pre-defined agenda to review the quality performance, ensure highlights are captured and drive continuous quality improvement plan.
Provide training (e.g. GMP training) and coaching to build up the team’s quality mindset and capability.
4. Drive and support the daily business by implementing end-to-end quality oversight of GMP in scope.
Be responsible for product releasing as QP.
Lead, negotiate, review and implement Quality Agreements with business partners and third parties in scope to ensure compliance with current regulations, Asieris quality standards associated with the activities to be carried out by the third party.
Ensure that the Third-Party qualification is completed before the contract becomes effective and GMP operations start.
Be responsible for oversight the qualification and validation including but not limited to equipment qualification, process validation, shipping study, stability study etc.
Evaluate and follow up on change controls and escalate as needed.
Ensure Quality Systems at Third Party site are in line with Asieris expectations, through appropriate oversight and efficient analysis tools.
Be responsible for Supplier Management.
Investigate major/critical deviations, issues, or technical complaints within the time frame defined. Escalate, manage and support issues management include but not limited to Product Quality Complaint management, Deviation Management, OOS, CAPA etc.
Audit management including self inspection, supplier audit, CMO audit etc., per business needs and requirements.
Ensure proper archiving of quality records documentation to guarantee traceability during the required retention period, by procedure, as relevant.
任职资格项Qualifications
学历/专业Education/Majors
Bachelor degree or above, major in Pharmacy, Pharmaceutical Analysis, Pharmaceutics, Pharmaceutical Engineering, Chinese Materia Medica or other pharmacy-related disciplines;
本科及以上学历，药学、药物分析、药物制剂、制药工程、中药学等药学相关专业。
工作经验要求Working Experience
5年以上制药行业质量管理经验，熟悉NMPA, FDA, EMA的质量法规和标准。
5+ years in pharmaceutical QMS, with expertise in NMPA, FDA, EMA.
MNC公司相关经验（生产和/或第三方生产）优先。
MNC related experience of on-site manufacturing and/or with external manufacturing parties is preferred.
知识技能水平
Knowledge and Skills 精通《药品管理法》、现行中国 GMP、中国药典、ICHQ7/Q9/Q10；熟练掌握偏差、变更、OOS、验证、供应商审计、批放行、产品召回全套体系实操；熟悉数据完整性要求。
Proficient in China GMP, Drug Administration Law, ChP, ICH guidelines, deviation/change/OOS/validation/recall management and data integrity requirements.
能力素质要求Competences
流利的英语沟通能力
Fluent in English