A large pharmaceutical company in Shanghai, is looking for an experienced and talented Quality Assurance Manager to join their team. You'll be responsible for the management of the quality system processes and procedures and the Quality Assurance team.
- Managing departmental objectives and budget.
- Managing a risk based internal audit system and continually review and develop appropriate metrics for QA annual Trend Analysis including tracking and trending of CAPAs.
- Managing the risk-based service provider audit programme and perform key service provider audits as required.
- Planning, co-ordinating and following-up on the internal and external audits undertaken by the auditing team.
- Managing and host regulatory authority inspections and sponsor audits by the Quality Assurance team.
- Managing the QA team workloads.
- Undertaking team appraisals.
- Providing operational staff with expert advice and support in relation to good quality practice regulations and guidelines and process knowledge.
- Developing, organising and providing quality management and regulatory training for all staff, consultants and where required Sponsors.
- Responsible for the management of SQN-Clinical eQMS (Q-Pulse) system
- Deputises for the archivist as required.
Skills and Requirements
- Bachelor's degree or above major in Chemistry, Material Science, Pharmaceutical, life sciences disciplines, etc.
- At least 5 years of working experience in cosmetic production or quality department in GMP/GSP environment.
- GMP experience will be preferred.
- Good understanding of Quality System regulations and requirements and ability to identify opportunity for improvement and implement improvement.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.