Provide quality oversight of local Drug Product life cycle and E2E manufacturing/Packaging process.。
. Provide quality oversight of site PUW, PW, Environmental Monitoring (EM) and Clean Utility Monitoring
programs as well as QC lab, warehouse operation.
. Oversee Batch Record Review and Batch Disposition process for all local manufactured/packaging
. Provide QA oversight of Planned Event (CAPA) and Unplanned Event (discrepancies and complaints)
execution to ensure quality and compliance of these activities meet PQS and HA requirements.
. Responsible for escalation of significant quality issues following the criteria as defined in the current
3. Principle Roles & Responsibilities / Accountabilities
● Experience (may vary depending on site size/scope)
. 5 or more years’ work experience in the pharmaceutical or related industry
. 3 or more years’ experience in a commercially licensed GMP facility
. Professional knowledge of Quality System and QA principles, practices and standards for the
. Rich knowledge of cGMP relevant to the pharmaceutical industry
. Knowledge of pharmaceutical, biotechnology or medical device related product operations including
local and international quality regulations.
Project management skills
. Demonstrate good verbal and written communication skills in English
. Focus on value and customer / . Learn for the future /