Build and develop site quality organization of new site to ensure sufficient resource and capabilities in place for the quality operations and continues improvements.
Set up validation master plan for the project, ensure timely completion of facility/equipment/utilities qualification and process validation.
Design, establish and implement site quality management system to ensure site operation fully complies with company standards and customer expectations.
Ensure operational readiness of QC lab to support project qualification, validation activities.
Assess and approve raw material and service suppliers according to global quality requirements.
Support tech transfer of products from giving sites and ensure equivalent quality.
Provide quality oversight of the entire manufacturing site
Responsible to make quality decision for product disposition.
Qualifications
Minimum bachelor’s degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or a related discipline.
A minimum experience of 15 years, with 5 years of supervisory position, in the pharmaceutical, biotechnology or medical device in quality assurance, GMP compliance, operations or validation, ideally in a multinational company.
