QC technical manager
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.
