北京招聘

Job Purpose
Provide Leadership and technical competencies for the QC lab to ensure on-going compliance with regulations and Health Authority expectations and inspection readiness.

Major Accountabilities
1. Demonstrated QC experience as well as leadership skills in lab.
2. Mentor, coach and train lab personnel, to ensure that the required initial and continuing training of lab personnel is carried out and adapted according to need.
3. Ensure adequate planning of routine lab testing and other testing activities (e.g. stability, investigations)
4. Participation in establishment, implementation and maintenance of the quality system in lab, and to strengthen lab quality systems and processes continually.
5. Management of the Site OOS and Stability Committee.
6. Authorize written procedures and other documents which related to QC lab.
7. As the delegation of Head of QA/QC, to approve or reject starting materials, packaging materials, and intermediate, bulk product in relation with their specification
8. To ensure the adequate facilities, trained personnel and approved procedures must be available for sampling, inspecting, and testing starting materials, packaging materials, intermediate, bulk, finished products, and where appropriate for monitoring environmental conditions for GMP purposed.
9. To ensure the samples of starting materials, packaging materials, intermediate products, bulk products and finished products must be taken by methods and personnel approved.
10. To ensure that the necessary and relevant tests are actually carried out. The materials are not released for use and no products are released from QC, until their quality has been judged to be satisfactory.
11. To ensure the records must be made demonstrating that all the required sampling, inspecting and testing procedures have actually been carried out and that any deviations have been fully recorded and investigated.
12. To ensure the records must be made of the results of inspecting and testing against specifications; product assessment must include a review and evaluation of the relevant production documentation and an assessment of deviations from specified procedures.
13. To ensure the sufficient samples of starting materials and products must be retained to permit future examination of the product if necessary; the retained product must be kept in property.
14. To establish, validate and implement all QC procedures in lab (e.g. sampling instructions, specifications, test methods and other QC procedures)
15. Technical support for in-process controls lab.
16. To participate in the investigation of complaints related to the quality of the product,
17. To ensure the maintenance /qualification /calibration of control instrument in lab are carried out.
18. To ensure the reference standards were evaluated, maintained, stored and used in lab.
19. To ensure all the QC operations should be carried out in accordance with written procedures and in compliance.
20. Participation in environment monitoring in site.
21. Participation in validation program.
22. Participation the regular internal audits or self –inspections.
23. Participation in external audit if necessary (contract lab);
24. Ensure health & safety procedures are followed i,e. near miss accidents, workstation assessment etc.

Requirement
Education:
BS/MS in Analytical Chemistry/ Pharmaceutical Chemistry/Chemistry/ or related discipline.
Languages:
Fluent English, Chinese is preferred.
Experience:
1. Minimum 5 years’ experience in a regulated pharmaceutical laboratory.
2. Have lean& 6 Sigma knowledge.
3. Good people-management and leadership skills, can energize direct reports and can drive high performance team.
4. Strong communication skill, interacting with people from interface functions in the local and global Novartis network as well as regulatory bodies. Taking the lead for resolving GMP and GxP related issues
5. Customer oriented and collaboration with local regulatory bodies and other Novartis sites as well as global functions.
6. Experience in Process or Operation in PU is preferred.

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