Responsibilities:

• Managing and supervising the documentation team to ensure that documentation processes performed in a timely manner.
• Managing local change control to ensure that change control processes performed in a timely manner.
• Review and continually improve local documentation and change control processes based on the implementation of global quality standards and cGMP, ICH Q7 and Q10 and ISO9001 requirements.
• Develop Quality KPI metrics to monitor and manage the documentation and change control, deviation and CAPA processes.

Qualifications

• 5 years of experience working experiences in QA/QC functions, cGMP and ICH Q7.
• Working experiences in pharmaceutical and/or chemical industries. 
• Background in quality control / assurance/Validation and qualification activities.
• Good analysis, troubleshooting, investigation