天津招聘

Strong players in strong teams

We challenge conventions and create sustainable solutions for the world around us by having strong players in strong teams. At Novozymes you will be teamed with passionate and dedicated colleagues who will challenge you to perform you best while supporting you along the way.

Senior cGMP Compliance Advisor (Case no: NZPCN 206 )

For our subsidiary Novozymes (China) Biopharma, located in TEDA, Tianjin, we wish to recruit a Senior cGMP Compliance Advisor in Biopharma China team. He or she will responsible for providing expert guidance and direction on compliance aspects re-garding quality assurance and validation in the ICH Q7 compliant TEDA Biopharma operation for new and existing products. Main responsibilities as below,

· Responsible for addressing compliance aspects and issues cross-functionally at bHA facility. Ensure to give effective advice to enable site management team to execute effective leadership of quality management enhancement activities. Ensure that the Site Director and QA manager are kept informed of all critical and major issues which may have an adverse affect on the quality of the product. Provide coaching and direction for QA manager, department managers, and team leaders.

· Ensure that cleaning and process validation activities is planned and executed in accordance with the established procedures and in accordance with ICH Q7 requirements. Participate in or manage quality and validation assessments related to introduction of new products into the facility. Provide direction for development of cleaning and process validation strategies and master plans. Review and approve high level quality documents and validation master plans and reports.

· Direct and support the resolution of quality and validation problems in the facility activities so that they are consistent with global industry and company standards. Challenge and review operations, project and validation activities and monitor pro-gress and initiate corrective actions and/or improvement projects. Perform review of compliance at department and individual level and propose corrective actions.

· Support and supervise quality and validation governance through review of project documents, KPIs, Risk Assessments, quality plans and validation plans.

· Identify and support continuous improvement projects in collaboration with site management team across functions with the objective of achieving quality, reliability and cost improvements. Ensure that coordinated contact is maintained with other functions within Biophar-ma, including sharing of better practices and procedures. Provide training to relevant staff, as requested.

· Attend preparation and execution of customer and regulatory audits on the site.

You will report to Site Director of Biopharma Plant, TEDA.

Qualifications

· University degree - Master’s Degree / Bachelor, Engineer, Science Biochemistry, Chemistry, Microbiology int. degree or similar.

· Minimum of 10 years of progressively more senior experience in professional international biopharma but must include minimally 5 years in QA and/or Validation, and 3 years of management.

· Strong understanding of regulatory guidelines for the Biopharma industry includes a pragmatic approach to implementation of guidelines.

· Excellent writing and oral communication skills and comfortable at delivering data and information to colleagues at all levels. Fluent in speaking / writing in English is a must.

· Extremely high energy, work ethics, and stamina to perform consistently at a high level in a very demanding environment.

Challenges

The candidate must get familiar with HA production activities, and enhance/keep high compliance awareness in cross-functional departments at site. Meanwhile, he or she need continually develop organization’s compliance competence and secure facility compliant to Q7 all time.

Rethink tomorrow

Novozymes is the world leader in bio-innovation. We create tomorrow’s solutions by applying technology to nature, to the benefit of both our customers’ bottom line and the planet. Novozymes serves a broad array of industries using enzymes, micro-organisms, biopolymers, and biopharmaceutical ingredients.

With over 700 products in 130 countries, Novozymes’ bio-innovations improve industrial performance and safeguard the world’s resources because they represent superior and sustainable solutions for tomorrow’s ever-changing marketplace.

Contact

Contact information: www.novozymes.com/careers and www.novozymes.cn/careers

Please send your application and CV in English (mandatory) and Chinese by e-mail to: possc-rec@novozymes.com (请注明申请职位的名称和编号，并务必提交英文简历)

Location

TEDA Tianjin, Biopharma Plant

诺维信（中国）生物医药有限公司
诺维信（中国）生物医药有限公司是诺维信公司在天津开发区除诺维信（中国）生物技术有限公司外兴建的第二家工厂。新的生物医药工厂初期将生产以芽孢杆菌发酵的透明质酸（bHA）产品，该产品适用于医疗器械和医药应用，如眼部护理等。后续还将建设一系列的原料药和用于医药工业的药物成份车间。新工厂在2009年至2010年的投资额将为2～3亿丹麦克朗（约为3500～5000万美金）。一季度已竣工投产。新工厂将生产符合世界绝大多数国家药监部门规定的药用标准的医药级透明质酸产品（Q7）。在投资兴建透明质酸生产工厂的同时，诺维信还正在规划药厂的扩建，建设一系列原料药和用于医药工业的药物成份车间，公司现有职工105人。

诺维信 重塑未来

    诺维信是引领生物创新的世界先导，总部位于丹麦首都哥本哈根。我们与众多行业客户携手，开发面向未来的工业生物解决方案，促进客户业务发展，改进地球资源的使用方式。诺维信的700多种产品遍及全球130个国家，世界市场份额超过40%。
    诺维信致力于探索生物技术及其应用，构筑起以微生物筛选、基因克隆及表达、蛋白质工程、代谢工程和菌种改良等为核心的生物技术平台。4500多项专利见证了我们对自然潜力永无止境的探索，展示出自然与科技结合所产生的强大力量。
    诺维信的酶制剂在洗涤剂、纺织、淀粉制糖、燃料乙醇、食品、皮革、造纸、啤酒酿造和饲料等工业领域有着广泛应用；通过替代或减少有害化学品的使用，降低水、能源和原材料的消耗，帮助加速或简化工艺过程，节约成本，提高经济和环境效益。
    诺维信生物公司的微生物产品被广泛应用于公用及家居清洁、废水处理、水产养殖及农业等领域，以清洁环保的方式有效解决多种环境问题。目前，诺维信已将业务范围拓展到生物聚合物和生物医药成分领域。


诺维信在中国

    诺维信是丹麦在华最大投资企业之一，自1994年起累计投资2亿美元，在天津经济技术开发区建立了全球酶制剂生产基地，在北京中关村科技园区设立了中国首家外资生物技术研发中心。此外，诺维信在江苏太仓建立了苏州宏达制酶有限公司；在沈阳设立了微生物生产基地；销售网络遍及全国。
    中国在诺维信全球化战略中占有举足轻重的地位，已逐渐成为诺维信最重要的业务增长引擎和研发、生产及运营中心。为了更接近蓬勃发展的中国市场，以更灵活高效的方式满足中国客户的多样化需求，诺维信正在将越来越多的功能和业务重心转移到中国，并在本地广纳贤士。
    在中国，诺维信秉承经营业绩、环境表现和社会责任并举的“三重底线”，积极研发适合本地市场的新产品和新应用，解决中国工业和工艺所面临的问题；同时投身地方环保事业，支持大学环境与生命科学研究及教育，倡导和推动生态工业与循环经济，立志成为中国***生物解决方案提供商和可持续发展的战略伙伴。

招聘官网：http://www.novozymes.com/asiapacific-cn/novozymes-in-china/career-in-china/pages/default.aspx