1、Sets the analytical, GMP and HSE standards for all aspects of development projects of her/his responsibility in alignment with Novartis regulations and network decisions;
2、Develops and validates methods together with a team of Analytical Lab Technician;
3、Author, reviewer and/or approver of GMP relevant documents (e.g. analytical methods, SOPs, qualification reports for analytical instruments, etc...);
4、Writes, checks and/or approves analytical documentation and writes/reviews reports (internal and reports to health authorities) and ensures adequate distribution of the information (e.g. in the project team);
5、Approves and releases batch records and qualification documents according to SOPs;
6、Fulfills all responsibilities according to CHAD GMP Responsibility List and the general responsibility list;
7、Defines the analytical strategy of development projects (proposes specifications, identifies by- and degradation products, re-test dates, storage conditions, and/or batch release decision according to analytical results, SOPs, and Novartis guidelines);
8、Co-author of regulatory CMC documents; provides answers to Health Authority requests in her/his field of expertise;
9、With increasing Job grade: Takes over the responsibility for the analytical strategy of more development projects of increasing complexity and importance;
10、With increasing Job grade: Defines the analytical strategy and has the oversight of all analytical aspects of an increasing number of development projects and acts as a supporter/mentor for less experienced colleagues;
11、With increasing Job grade: Increasing analytical know how (Methods, SOPs, Development Manual, GMP requirements);
12、With increasing Job Grade: Increases her/his knowledge of analytical techniques (additional techniques or in depth understanding in few techniques);
13、Pro-actively identifies scientific, technological and GMP issues and proposes solutions to these towards the CDU operations team, the Analytical Network, and the GMP Network;
14、Ensures the distribution of lessons learned and scientific know-how in his unit or across units。
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1、Passion for analytical work;
2、Know-how in at least one analytical technique (e.g. HPLC; GC, Titration, IC, LC/MS) in academia or industry;
3、Scientific, analytical and entrepreneurial thinking;
4、Good communication and leadership skills;
5、Software know-how: Office package, analytical software (e.g. Chromeleon)。
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