北京招聘

Main responsibilities would include：
？ For new investment projects
? Develop qualification strategy from Project URS to handover, with support of project engineers and compliance engineers.
? Support project engineers and compliance engineers to prepare validation master plan for the project which defines all actions, deliverables, responsibil-ities and procedures to satisfy the user/customer and product quality and val-idation requirements.
? Attend GxP Risk Assessment and assist on report review.
? Prepare all tests protocols, e.g. Commissioning, DQ, IQ, OQ in compliance with Novartis standards.
? Support project team and site engineers in tests protocols (Commissioning, DQ, IQ, OQ) execution. And be responsible for report review.
? Lead assigned internal and external resources in tests protocols (Commis-sioning, DQ, IQ, OQ) preparation and execution, for certain projects if appli-cable.
? Responsible for the input of process/functional changes to engineering com-pliance. And provide risk assessment for change control (GMP related) if re-quired.
? Attend project handover with site engineers and compliance engineers.
？ General:
? For BNP site process & equipment change, and regular GMP Qualification, be responsible for preparation qualification protocols in compliance with Novartis standards.
? Assist engineers in qualification protocol execution. And be responsible for qualification reports review.
? Support compliance engineers to lead and facilitate the sharing and leveraging of local best practices in technical compliance.
? Responsible of Asset Change Control (Technical Change) activities.

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