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New Beta Innovation Canada Limited

Project Lead, Quality Assurance (Compliance)

Location
Burnaby, BC
Details
Full Time
7 days ago

ABOUT THE COMPANY

New Beta Innovation Canada Limited (NBI-CA) 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.

POSITION OVERVIEW

Reporting to the Senior Manager, Quality Assurance (Compliance), the incumbent will be working alongside and supporting QA team to implement the electronic Quality Management Systems (eQMS) and site document management program.

KEY RESPONSIBILITIES

  • Lead eQMS projects by coordinating with different stakeholders and provide regular updates to the senior management
  • Responsible for effective implementation of eQMS system
  • Provide and/or coordinate trainings related to eQMS systems for cross functional teams to achieve the relevant goals timely
  • Act as system administrator for eQMS systems and provide routine support as required
  • Troubleshoot eQMS issues in timely manner by coordinating with different stakeholders as required
  • Provide support in management of the documentation system of the company including management of document archive room
  • Provide project management support to Compliance team
  • Provide support to continuously improve eQMS SOPs including but not limited to Deviation, Change Control, CAPA, quality risk management, GDP, Audit, Supplier/Outsourced Activity Qualification, Specification and Data Integrity
  • Perform other duties as assigned

KNOWLEDGE, SKILLS AND ABILITIES

  • Bachelor’s Degree in Pharmaceutical, Biopharmaceutical, or relevant field
  • Minimum 5 years of experience in pharmaceutical or biopharmaceutical with minimum 3 years of experience in electronic document management systems
  • Strong project coordination/ management skills. Certification on project management is an asset
  • Good understanding on pharmaceutical or biopharmaceutical QMS including but not limited to document management, change control, training management, deviation, CAPA, audit etc.
  • Strong Knowledge of pharmaceutical or biopharmaceutical cGMP
  • Ability to work independently and in a team environment
  • Work efficiently with the ability to be innovative and identify creative solutions
  • High proficiency in MS Word/Excel and good writing skills
  • Strong sense of pride in ownership of, and quality of work
  • Strong organizational skills and attention to detail

WHY JOIN NBI?

The best reason is because of our wonderful people and great work environment. If you are looking for a career with meaning and purpose, it’s hard to beat working in life sciences. We provide an attractive compensation and benefits package which recognizes people for their contributions, and comprehensive training and career development opportunities which support our employees’ growth with the company.

If you are interested in joining our team, we encourage you to APPLY today!

Category
Biotechnology Quality Assurance