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QC technical manager

Ort Wuxi, Jiangsu Sheng, China Anzeigen-ID R-104388 Veröffentlichungsdatum 04/01/2021

Responsibilities:

Maintain / improve GMP compliance in daily Analytical Lab operation.
Manage analytical lab technical supporting team and be responsible for team and personnel capability development
Lead the initiatives for quality control procedure or management continuous improvement
Contribute to the QA function in developing / improving quality management system
Management of Analytical Lab affairs
Maintain / improve GMP compliance in daily Analytical Lab operation.
Has a direct involvement in regulatory inspections
As technical consultant in analytical technology transfer
Provides analytical expert knowledge and support to the complex troubleshooting issues, novel situations and oversees the delivery of training and coaching
Major/Critical problem solving and issue management
New technologies, product transfers, product expertise, CMC dossier support and major change/project management
Continuous Quality Improvement
People management
SHE responsibility

Requirements:

Degree or equivalent professional qualification in a science/technical field such as Pharmacy, Biology, Chemistry.
10+ years prior experience in GXP environment of pharmaceutical industry
6+ years prior experience in quality control – analytical
Excellent command of English
Experience of analytical method transfer or validation.
Experience of people management
Experience of leading pharmacopeia change project
Knowledge and a comprehensive understanding of the principles and concepts of compliance management and Good Manufacturing Practice/Good Laboratory Practice
Overall quality management system and GMP knowledge
Capability of providing direction to the analytical lab including instrumentation and methodology troubleshooting, non-routine analysis, and the evaluation and exploitation of new technology.
Good collaboration, team coaching and people development capability


AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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