Senior Scientist, QA systems & Compliance

at  Thermo Fisher Scientific

JOB DESCRIPTION

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Position Summary: This position is expected to be QA expert for multiple system elements, has deep understanding in quality computerized systems, assist deployment of corporate policy at site, PQR and events management. Understand basic quality tool, find opportunity to improve the process proactively, provide mentorship to other departments for basic quality process and cooperate to complete job.

EDUCATION:

• Degree (Diploma or Master) in Life Sciences (Biology, Chemistry, etc.) or Engineering.

EXPERIENCE:

• At least 3 years of Quality experience in pharmaceutical.
• Experience in Quality Management System.
• Experience in biologics and aseptic training.
• Experience in Deviation, Change Control, CAPA management.
• Knowledge in Audit / inspections.

• Maintain QMS systems (e.g. TrackWise, eDMS, SFLMS etc.). Authors SOPs / Work Instructions related to QMS and ensure the SOP landscape operation readiness within LGN site.
• Lead corporate standards gap assessment, ensure site practice follows regulatory requirements
• Lead the maintenance of document and record management system, supervise the effective execution of site document management requirements.
• Responsible for maintenance of GMP training system, develop cross function training champion team, supervise and coordinate the effective implementation of site training and personnel qualification. Support the training lead and coordinate GMP training. Introduce, develop and improve site GMP readiness.
• Lead the annual product quality review.
• Assist Practical Process Improvement (PPI) activities.
• Supports the management and administration of Inspections and Audits at the site
• Complete any other related work assigned by company