Ensure
that the site Quality Systems are compliant with the company’s quality
Manual and all relevant regulatory and legislative requirements.
Lead the development, maintenance and rolling review of quality systems to support site business continuity.
Establish
and maintain Quality System for the site; ensure that Quality System
and Standard Operating Procedures are in place and that compliance with
cGMP is maintained.
Monitor
and evaluate the level of cGMP compliance for products manufactured,
packaged, tested and released at local and regional (delegated) third
parties through Key Performance Indicators (KPIs) and Key Quality
Indicators (KQIs).
Continuously
improve and harmonise the site Quality Systems, strengthen quality
awareness, support contract operation, technical services, process
improvements, product quality review, eliminate barriers and proactively
support the investigation of quality issues using appropriate process
improvement and problem solving techniques.
Ensure
that the OU QA activities operate in a cost effective and efficient
manner and maintain an innovative approach based on productivity
improvement and implementation of best practice.
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