上海招聘

Title: Validation/qualification Pharmacist
Department: Compliance/Quality Assurance
Reports to (Function) 汇报上级: Head of Compliance

Job Purpose (State in one sentence the overall objective of the job)
工作目的（概括总的工作目标）
Assure the Product Quality conforms with specifications and that Products’ production activity compliance with Novartis Quality Policy and GMP requirement. Assure local concept/guidelines and management for change control, validation/qualification are aligned with cGMP and Novartis requirements.
Major Accountabilities (Describe the main results of the job to be achieved )
主要职责（描述该工作要达到的主要结果）

1. Manage Local Change Control system to ensure all changes that could affect product quality are suitably reviewed, approved before implementation; be responsible to review the implementation of the changes, ensure the timely implementation and proper documentation of change request.
2. Maintain Qualification/Validation System of BNP. Issue Validation Master Plan, site validation master plan, monitor the status of Qualification/Validation and ensure manufacturing process, equipment/ /utility and control instrument for GMP activities are validated/qualified. Review and check the Qualification/Validation documentation for correctness, completeness according to both technical and GMP specific requirement.
3. Provide compliance support with comments during qualification/validation related documents e.g. protocol and report preparation and review, provide compliance guidance and support during qualification/validation implementation.
4. Lead site validation/qualification status periodic review by product and by system.
5. To be trainer in change management area and validation/qualification area.
6. Provide effective compliance support and services to the others.
7. Responsible for master batch record preparation for process validation.

Other requirement
其它要求

1. Have logical thinking, strategic and analytical skills as well as a holistic approach to problem solving
2. Have the ability to perform multiple, overlapping tasks
3. Ability to effectively communicate with people
4. Positive attitude and excellent interpersonal skills
5. Work well under pressure


Ideal Background (State the minimum and desirable education and experience level)
理想的背景（教育和工作经验方面的基本要求）
Education:
教育
Bachelor degree above.
Languages:
语言
Effective oral and written abilities in English.
Experience:
工作经验 1. 4-6 years experience in the quality assurance field in Pharmaceutical industry, JV experience has priority.
2. Be familiar with the law and regulation for pharmaceutical manufacturing and in-depth understanding of current GMPs (MHRA, TGA, WHO GMP)
3. Practical experiences in Compliance and QC.

Pharma operation - 北京诺华制药有限公司 北京昌平制药工厂诚聘