苏州招聘

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: lebx@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 地址：天津经济开发区-滨海新区)

诺维信—引领生物创新的世界先导
诺维信公司是全球工业酶制剂和微生物制剂的主导企业，拥有超过40%的世界市场份额。诺维信的700多种产品遍及全球130个国家和地区。我们的生物创新为日新月异的未来市场需求提供卓越和可持续解决的方案，提高工业效率，保护世界资源。
诺维信每年投入净营业额的13%用于研发，致力于探索生物技术前沿，为工业提供可持续生物解决方案。诺维信生物公司提供的微生物产品广泛应用于公用及家居清洁、废水处理、水产养殖及农林园艺等，以清洁、环保的方式有效解决多种环境问题。目前，诺维信又将业务范围拓展到生物聚合物和生物医药成分领域。
7000多项专利见证了我们对自然潜力永无止境的探索，展示出自然与科技相结合所产生的强大力量。诺维信遍及全球的6000多名研发、生产和销售人员通过不懈努力，致力于改变当今业务模式，开创人类更加美好的未来。

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；在山东建立了创新与发展中心；销售网络遍及全国。

诺维信在苏州
苏州宏达制酶有限公司
苏州宏达制酶有限公司是诺维信公司和苏州宏达集团有限公司于一九九五年共同投资建成，外方公司控股。公司总投资约8亿人民币，占地约8万平方米，公司采用了诺维信先进的生物技术和管理理念, 实施可持续发展战略，倡导激情、活力、开放、科学的价值观，多年来秉承了对环境和社会负责的优秀企业文化。公司产品广泛应用于洗涤、纺织、皮革、酒精等工业，公司经过2006-2008三年的连续扩建已成为诺维信全球重要的生产基地，公司现有员工约270人。