北京招聘

Job Responsibilities工作职责
-了解工厂工艺设备状态，主导完成设备设施的风险评估，为工艺设备设施投资提供技术支持
-参与设备设施投资项目，给出技术意见和建议
-协同生产、工程等部门，为工艺设施设备的投资提供URS（用户需求）
-引进和推进工厂应用外部先进的技术，以提高工厂设备实施的先进性
-参与工厂设备验证，如IQ，OQ， PQ等工作
-参与偏差调查，应急事件的处理等，从设备技术角度提供技术意见

Requirement要求
-大学本科以上，药学、化学、化学工程、机械工程等相关专业
-5年药剂或化学合成药厂的工作经验
-英语流利

Details pls find below:
Major Accountabilities (Describe the 5-7 main results of the role to be achieved )

Knowledge management:
- Owns the knowledge of specific pharmaceutical, chemicial manufacturing enigneering technologies, locally, including any support for URS writing, participating in investment projects, risk assessment reviewing and equipment qualifications
- Provides and assures the fundamental knowledge in the specific area of expertise through the provision of regular training and education programs for Process Experts and Operators.
- Assures that the necessary benchmark is done internally in Novartis, and externally in the scientific and academic environment, in order to stimulate and to extend the knowledge, increasing the know-how of the associates and expanding it to the rest of the organization.

Subject Matter Expert SME for Technology platform:
- Deep Subject Matter Expertise for specific Technology Platform or pharmaceutical and chemicial engineering (eg, packaging line, blending, reactor) following process product/process transfer or handover from launch to commercial production.
- Designs and controls optimization projects relevant to his/her specific expertise.
- Provides SME expertise to perform process characterizion of the related process and equipment to increase robustness and sustainability.
- Supports Process Experts and Product Stewards in trouble shooting by providing second level of specialist expertise as Subject Matter Experts and by harmonising and optimising related technical processes across the units.

Single Point Of Contact (SPoC) for the technology
- Acts as the SPoC for the interface with global MS&T network and with technical development organization, for the corresponding global activities, to define and implement new technical standards for existing and new technologies and equipment (e.g., manufacturing equipment, Process Analytical Technologies PAT).
- Collaborate with technical development, other sites and global MS&T network to facilitate transfer of technical knowledge.
Responsible to perform technical feasibility trials related to process improvement and implementation of new manufacturing technologies.

Selection of process equipment
- Participate in the definition and selection of synthesis and formulation equipment, through providing input to User Requirements (URS).
- Participate in equipment quailification activities (e.g. IQ, OQ, PQ etc.)
- Support product stewards to complete product transfer or new product launch within equipments’ technical scope.

Audit support
- Maintain their work in inspection readiness level and provide the necessary support in any internal or external audit in addition to providing input to and review regulatory documentation.
- Participate in due diligence team, where applicable, for process equipment related investment projects.

Training
- Own the Training Curriculum for its Job Profile and provides the necessary training and support to new associates joining this position.
- Provide the necessary training and education on related technologies to Process Experts, Product Stewards and Operators.
- Be a recognized scientific expert internally and externally by reporting and presenting scientific/technical work at internal/external meetings/conferences and publish in peer reviewed international scientific journals including patents.



Key Performance Indicators (Indicate how performance for this role will be measured)

- Batch release on time/in quality.
- Line throughput time.
- Number of Deviations.
- Effective CAPAs.
- CpK – process capability.
- OoS, OoE – Out of Specification, Out of Expectation.
- Yield.
- Customer Complaints.
- Number of Recalls.
- Success rate of internal audits and Health Authorities' inspections.

Dimensions of the Job (Indicate key facts and figures)


Number of staff reporting
- Direct: None.
Financial responsibility
(Budget, Cost, Sales, etc.)
- Operational Budget: none.
Impact on the organisation - Contribute to Site Manufacturing financial /business goals.
- Minimize rejected batches and write-offs.
- Maximize Yield improvements.

Ideal Background (State the preferred education and experience level)

Education (minimum/desirable): - BSc. in Pharmacy, Pharmaceutical Technology, Chemistr Engineering, Mechanical Engineering or equivalent scientific degree.
- Desirable MSc. or equivalent experience.

Languages
- Fluent in English and Mandarin
Relevant Experiences - Minimum 5 years experience in GMP manufacturing relevant to the specialist area of expertise.
- Proven process understanding (Pharma, GMP, Regulatory aspects).

Shanghai Novartis Animal Health Co., Ltd. (SNAH) is a joint venture invested by Novartis Group (Switzerland) and it's China partners. SNAH was established in 1990 with total investment of .CHF50 million. Headquarter of SNAH locates in Shanghai, and it's 39,000m² affiliated manufacturing plant is in Wusi Farm, Fengxian County. The production lines were formally launched in 1994.
Shanghai Novartis Animal Health Co., Ltd. is the first animal health enterprise been awarded with GMP certificate by Minister of Agricultural in China. SNAH introduces advanced production line, equipment and know-how to manufacture, formulate and repack animal health products. With our complete quality control system, the products are guaranteed to meet both local and international standards. Our products supply to domestic market, and also export to South East Asia, Australia, Africa, Europe, etc. Most of them are re-sale to Switzerland.
For more information please visit our website.
We are committed to build sustainable competitive advantage through the quality, capability and performance of our people. We are currently looking for:

Novartis will provide attractive salary package, benefit and career development opportunities.
Interested candidates please send your CV both in English and Chinese, current and expected salary to us and write the position title on the envelope.