北京招聘

Job Title: Statistical Champion
Job Grade:
Department: MS&T
Reports to: MS&T Head


Job Purpose (State in one sentence the overall objective of the job)
The associate is responsible to provide statistical support for the site and within the global network. In his or her role the person will provide statistical assessments and develop models for process improvements, monitoring and control purposes. Furthermore, the associate will actively be involved in troubleshooting and process validations activities, which includes adherence to regulatory and GMP requirements.
Major Accountabilities (Describe the 5-7 main results of the job to be achieved )
The associate will support PharmOps site XXX and the global network and will be responsible for all statistical tasks with a high level of independence for the following areas of activities:
1. Process Validation and Transfers:
? Set up and evaluation of DoEs in the frame of the Novartis QbD validation strategy
? Statistical analysis of process validation data for proving validity and equivalence, e.g. Bergum approach, f2 assessments for dissolution profiles
? Contribute in risk assessments, e.g. FMEA or risk matrix
2. Trending analysis in the frame of Continuous Process Verification
? Analysis of inter and intra batch variability by process monitoring and control charts
? Support the compilation of APQR
? Facilitate and enable (multivariate) statistical process control, e.g. by MVDA
? Review of stability data and definition of internal release limits
3. Root cause investigation (as a follow up action of an OOS and process deviation)
? Support the analysis of complex data sets e.g. by rRCI or MVDA
? Accountable for statistical conclusions
4. Analytical method validation and transfer, in particular PAT methods
? Support the design of an analytical robustness test, e.g. by means of DoE
? Statistical assessment of method validation data and site transfer
? Development and validation of multivariate models for on-line PAT methods
5. Process improvement (also in alignment with IQP)
? Capability and stability assessments
? Models for facilitating process improvements, e.g. DoE, MVDA, CFD, multi linear curve fitting etc.
7. Training
? Conduct training on available tools and how to use them
? Instruct how to interpret data and statistical results highlighting constraints and limitations

The associate will actively participate in IQP Champions and PAT TechOps Best Practice Network.
The person will work with and deliver results to
o Process Experts of the process units
o QA/QC representatives
o MS&T peers
o IQP site champion
o GPE PAT group , RegCMC and TRD on a global level


Key Performance Indicators (Indicate how performance will be measured: indicators, activities)
? Customer Satisfaction:
Provide statistical consultancy and services.
(Project milestones and timelines, excellence in communication.)
? Quality:
State of the art methodology in accordance with internal and external standards (SOPs, validation guidelines)
(Development of Statistical model and application and provide adequate support with the result of increase of Quality capability.)
? Cost:
Better yield, better process capability resulting in less write-offs, (cost of poor quality)
? Productivity:
Support process improvements in the frame of IQP projects, TLCM or process launches/transfers and expedite solution findings as part of root cause investigations
? GMP/HSE compliance:
Responsible for the compliance of sections with statistical content in GMP and regulatory relevant documents also in the light of inspections
? Operational:
Leadership of Statistics. Ensures flawless flow of information through cross functional teams to achieve process improvements and operational excellence.

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