现场QA主管（香港）

Job Type   /   Job Level

Full-time   /   Senior Executive

Company Location

Hong Kong

职位来源于智联招聘。

岗位职责:

根据生产计划，制定现场QA工作的日常安排和管理；
负责关键工艺运行情况和关键生产过程参数（CPPs）的验证；
根据不同剂型的生产过程，规范化现场QA工作流程和操作步骤；
制定设施、厂房、公用设施和仓库的审核计划，并审查其实施情况；
制定现场质量控制相关的SOP；
定期对现场质量控制人员进行培训和评估；
为生产人员在执行偏差、变更和CAPA过程中提供支持；
负责生产记录的审核；
协助进行产品质量审核；
领导交办的其他工作。
According to the production schedule of each process, arrange the schedule of production QA periodically.
Verify the operation of critical processes and the critical process parameters (CPPs)
Standardize the workflow and operation steps of on-site QA according to each process of different dosage form.
Prepare facility, premises, utilities and warehouse inspection plan and review the implementation.
Prepare related SOP for on-site QA.
Training and assessment on-site QA periodically
Provide support for production personnel in the execution of deviation, change control and CAPA
Review batch processing records.
Assist in product quality review.
Other assignment of QA Manager.

任职要求:

本科以上学历，药学/理学/应用科学相关专业；
3年以上QA部门经验；
熟悉口服固体、口服液和乳膏剂型；
熟悉PIC/S或者GMP要求；
英语书面精通，口语能进行常规交流，会讲普通话或广东话；
熟悉EXCEL、word、PPT等办公软件。
Bachelors degree or above in Science / Applied Science/ Pharmaceutical Study or equivalent.
Above 3 years work experience in QA department.
Familiar with oral solid, oral liquid and cream dosage forms.
Familiar with PIC/S GMP requirement.
Fluent in spoken and written English, Cantonese or Putonghua.
Goods computer skill in words, power points, excels.

以担保或任何理由索要财物，扣押证照，均涉嫌违法。

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