KEY RESPONSIBILUTIES:
1. Maintain the CSL quality management system in CSL China & Hong Kong markets to ensure corporate, regulatory and GMP/GSP/GDP compliance requirements continue to be met.
2. Ensure that local policies and procedures remain current in line with regulatory, statutory and corporate requirements.
3. Review and Approve functional documentation for the CSL China & Hong Kong business operations.
4. Manage, train and mentor Quality staff in the China office(s) on applicable GMP/GSP/GDP, CSL policies, procedures as required
5. Facilitate and administer for CSL China & Hong Kong change control process
6. Manage and conduct internal GMP/GDP audit program to monitor the compliance of China business operations
• Participate in organisational and individual staff training programs in CSL China & Hong Kong.
• Manage the development and training of GMP/GSP/GDP or other Quality training for the CSL China & Hong Kong Staff.
• Maintain internal key relationships with CSL Divisions: CSL Behring (USA, Germany, Switzerland and Australia). Maintain key external relationships with agents/distributors, licensors and partners within China & Hong Kong.
• Facilitate the transport release process between manufactures and distributors for shipments into China. Ensure Records of this process are maintained for China operations
• Managed and conduct GMP/GSP/GDP audits of China supply chain partners, provide audit reports in timely manner, assess audit responses and provide quality advice to maintain regulatory compliance and continuous improvement
• Manage quality agreements between CSL manufacturers and China Affiliate.
• Participate in adverse event and product technical complaint investigations on behalf of CSL Behring (as required).
• Review, risk assess, facilitate the timely investigation, implement CAPA, response, trend and monitor product technical complaints relevant to area of responsibility.
• Main person responsible for ensuring reporting of customer Product Technical complaints (PTCs) into the Global complaints database in a timely manner and aiding investigation if required

ESSENTIAL CRITERIA:
1. Tertiary Degree qualifications in s scientific or related discipline (e.g pharmacy, chemistry, Microbiology, Biochemistry or Chemical Engineering)
2. Excellent working knowledge of QMS, GMP/GSP (China) principles
3. Minimum three years’ experience in a QA/QC experience (Pharmaceutical or related industry)
4. Highly fluent in Mandarin and English (Written & spoken)
5. Well-developed planning, and time management skills
6. High level organizational and problem solving skills
7. High level verbal and written communication skills within a cross cultural and functional environment

其他信息

行业要求：全部行业