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1. Assist the GM to make development planand execute the plan.
2. Receive the inspection of FDA and to supervise and inspect
the daily operation following the law.
3. Provide technical support for the flying inspection of FDA to the
manufacture line of the parent company.
4. Fully responsible for the API manufacture, quality control,
technical operation transformation.
5. Responsible for the technical training and audit to the documents including the operation process, QA standard and other technical documents.
6. Resolve or organize relative departments to resolve all technicalproblems, quality problems in the operation process and to ensure smooth manufacture process and good product quality.
7. Responsible for the mid-work test of the product under research, PVB produce and relative work.
8. Responsible for the improvement of the manufacture process, product quality and technical reconstruction.


9. Set up and optimize the SOP and improve the rate of recovery, to decrease the manufacture cost of the products constantly.
10. Participate the construction of the new manufacture site and also their GMP and FDA inspection.
11. Assist the GM to manage the legality of operations. Ensure the safety of manufacture process, EHS, GMP management.
12. Report to the Head of the International Expert Team regularly. 13. Conduct the work independently and in a third-part angel.

14. Inspect and monitor the production quality and operation technology and toassess the key risks of the operation process and manufacture process.
15. Report the risks to the relative parties.

Qualification
1/. Bachelor or above level degree, major at Pharmaceutical Engineering,or Pharmacy, or Chemistry.
2.. 5 to 10 years of working experience in API produce or Quality Control, including 3 years and above senior management experience.
3. Strong academic background at API produce or Quality Control,
including but not excluded in new product technology transformation and mid-work test and amplify.
4. Familiar with the operation normal API produce equipment, and
know the capacity of the equipment, and be able to resolve most of the problems encountered in the produce process especially the
problems encountered in the process of technical amplify and
technical transformation.
6. Familiar with Regulatory Affairs, and have rich experience in CGMP onsite management.

7. Experience in CGMP operation. Be familiar with regulations in European, USA or ICH product research and quality assessment.
8. Be good at organizing team work and corporation with teams in other functions. Great leadership, good capability of expression, and good
capability in cross function or department communication.
9. Good at risk control in API produce and EHS management.
10. Better if the candidate has experience in construction and
construction management in manufacture site and plants.
11. We hope the candidate has working experience in API plants which has the capacity of 10-100 tons API product.
12. Experience in robotics is an added boost.

Mohit Kotwani 
hr@fstin.com

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