Reporting to the Manager, Quality Assurance, the incumbent will perform a variety of Quality Assurance related functions to contribute to the creation and implementation of the Quality Management System programme at NBI for sterile bio-pharmaceutical product manufacturing and aseptic filling.
• Write a variety of QA SOPs and maintain the QMS system per the current Health Canada, US FDA and GMP requirements • Review validation documents and ensure compliance to regulations and guidance • Support the NBI global procedure harmonization initiatives • Provide project support for the implementation and maintenance of the e-QMS system and ensure alignment with the NBI QMS system, and compliance with the GMP requirements from relevant authorities • Become a trained e-QMS key user and provide system trainings to NBICA and the other NBI sites globally • Assist with performing Quality internal and external audits as needed • Work closely with QA, QC, E&M and Production departments to achieve deliverables • Perform other related tasks as needed
KNOWLEDGE, SKILLS AND ABILITIES
• 5+ years relevant work experience in pharmaceutical or biologics manufacturing industry. • Degree in Pharmaceutical, Biopharmaceutical or relevant majors • Working knowledge of GMP regulations and QMS principles • Knowledge of Biopharmaceutical manufacturing process and product • Knowledge of aseptic processing is preferred • Capable of writing and reviewing Change Control, Deviation, CAPA and other quality documents • Excellent interpersonal skills, ability to work independently and in a team environment • Proficiency in developing innovative and creative solutions • High proficiency in MS Word/Excel and good writing skills
Additional Salary Information: Negotiable - depending on experience
New B Innovation Ltd. (NBI) is a preclinical stage life sciences organization in Burnaby, BC. Leveraging on our expertise in research and development, we are transforming drug discovery into clinical applications for unmet medical needs. We have ongoing collaborations with top universities worldwide on various research projects, with distinguished achievements in the areas of oncology, neurology, ...ischemic and hypoxic conditions.
Our state-of-the-art GMP manufacturing facilities and laboratories in Greater Vancouver are home to a growing team of professionals who are inspired to develop advanced life-saving hemoglobin-based therapeutics for the well-being of people.