Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
15 Years
Description
- 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
Highest qualification: University
- 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.
- Fluent in English.