Description
A world leading bio-pharmaceutical organisation is looking for a QA Validation Specialist to work on a major investment project in South-East Asia. The project is a $300m+ biologics site.The QA Validation Specialist will focus on the newly installed laboratory equipment in support of the main manufacturing. The first six months will be spent in the company`s global headquarters, after which activities will be spent on site.
Location: Switzerland (until Dec 2013), South-East Asia (from Jan 2014 onwards)
Duration: 18 months +
Role and Responsibilities:
- Reviewing DQ and equipment procurement documentation for technical integrity and GMP compliance
- Planning qualification and validation activities from the global headquarters (Switzerland)
- Executing IQ/OQ/PQ protocols and process validation tests on site (on site - South-East Asia)
- Providing QA oversight to all activities to ensure that the new site will be fully compliant
- Working with lab equipment such as HPLC, GC, UV, UF
Requirements:
- Engineering background with experience working on biopharmaceutical investment projects
- Experience planning, executing and reviewing qualification and validation of equipment and processes
- Experience working with lab and analytical equipment
- Strong GMP knowledge
- Confident working in international, multicultural environments
This is an excellent opportunity to work on one of the biggest start-up biotech sites in the world for a top blue-chip company.