长沙招聘

Key accountabilities:
1.Validation, calibration and maintenance management:
- Develop & update Validation Master Plan (VMP) and follow up .
- Review validation files：Equipment & Utility qualification, focused on Manufacturing equipment, Computerized system validation.
- Follow up the calibration plan and review the calibration documents.
- Follow up maintenance plan and review the PM documents.
- Define validation, calibration and Maintenance strategy, the necessary action, the responsibilities and the documentation in the validation procedure. Ensure validation compliance to cGMP
- Organize and communicate with related department for performing (preventive maintenance, calibration, periodic review and requalification activities
2. Change Control management:
- Monthly monitor the progress of applied changes and follow up with action plans;
- able to write change controls, deviations and CAPAs in a logical and clear method.
3. Purified water, HVAC and Compress air trend analysis

The candidate must have the following technical qualifications:
1、Bachelor Degree, and prefer Master degree in one of the following fields of engineering: mechanical engineering; chemical engineering; process engineering; pharmaceutical engineering
2、5 to 8 years of working experience in a GMP environment (US, EU, China)
3、At least 5 years of equipment validation experience for a foreign multinational in China
4、 A working knowledge of industry standards related production equipment in the pharmaceutical industry, e.g. ASME BPE
5、Experience with initial equipment validations (URS, DQ, IQ, OQ, PQ) and reviewing (reviewing qualification protocols before and after execution)

Other skills:
1、Language skills: Proficient in Chinese and English (especially written English)
2、Computer skills: MS Office software (Word, Excel, PowerPoint, Visio)
3、Show leadership within innerdepartment to coordinate, collaborate, instruct and lead to complete validation management work
4、Writing skills: Needs to be able to formulate thoughts on paper in a clear and logical manner
5、Motivated to learn, to apply, and to summarize through continual improvement.

Having the following is a plus:
1、Experience with oral solid dosage, particularly familiarize in manufacturing process
2、Experience with non-sterile manufacturing
3、QA background
4、Prefer candidates coming from AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Merck & Co, Novartis, Pfizer, Roche,
Sanofi-Aventis.etc

药明康德是国际领先的开放式能力与技术平台公司，为全球制药及医疗器械等领域提供从药物发现、开发到市场化的全方位一体化的实验室研发和生产服务。本着以研究为首任，以客户为中心的宗旨，药明康德通过高性价比、高效率的服务平台帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。药明康德平台涵括化学药研发和生产、细胞及基因疗法研发生产、药物研发和医疗器械测试等，正承载着来自全球30多个国家的3500多家创新合作伙伴的数千个研发创新项目，致力于将最新和***的医药和健康产品带给全球病患，实现“让天下没有难做的药，难治的病”的梦想。