锦鲤求职岗位描述
职责/Responsibilities
l 负责产品放行前的审核工作，及时反馈发现的各类问题与偏差，并协助问题整改。
Be responsible for reviewing finished products before release, promptly feeding back any identified issues or deviations, and assisting in resolving them.
l 评估产品是否满足放行要求，准确、及时出具成品放行审核表。
Evaluate whether the products meet the release requirements, accurately and timely issue the Product Release Review Form
l 协助建立并完善产品放行相关规程。
Assist in establishing and improving the procedures for product release.
l 作为放行SME，参与客户审核及官方检查工作，并负责跟进后续相关事宜。
As release SME to participate client audit and official inspection, and responsible for following up on related matters.
l 协助PM、QA及FL查找与放行相关的文件
Assist PM, QA and FL in locating release-related documents.
资质要求/Qualifications:
l 药学或相关专业本科及以上学历。
Bachelor's degree or higher in Pharmacy or related majors.
l 具有GMP 认证制药企业5 年及以上质量保证岗位工作经验，具有2年及以上现场QA及产品放行经验。
Minimum 5 years of Quality Assurance experience in a GMP-compliant pharmaceutical manufacturing environment, with at least 2 years of experience in on-site QA oversight and product release management.
l 全面掌握美国食品药品监督管理局（FDA）、欧洲药品管理局（EMA）及其他相关法规要求。
Comprehensive knowledge of FDA, EMA, and other regulatory requirements.
l 熟练掌握制药行业质量保证流程及法规指导原则。
Proficient in the quality assurance processes and regulatory guidelines of the pharmaceutical industry.
l 具备出色的口头与书面沟通能力，能够与各类利益相关方有效协作。
Excellent communication skills, both verbal and written, with the ability to interact with various stakeholders.