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Specialist/ Senior Specialist, Quality Assurance (Validation and Compliance)

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Burnaby, BC
Job Type icon
Full Time
Job Category icon
Biotechnology

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POSITION

Specialist/ Senior specialist, quality assurance

ABOUT THE COMPANY

New β 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.

POSITION OVERVIEW

Reporting to the QA Manager, 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 filing.

This is a 15 month contract for a maternity leave cover.

KEY RESPONSIBILITIES

  • Review and approve commissioning, qualification and validation documentations of equipment, utilities, facility and processes with the focus on cGMP compliance. Examples are but not limited to – URS, DQ, FDS, FAT/SAT documents/commissioning documents, IOQ, PQ, Validation plan, Risk assessment, validation summery report, SOPs
  • Maintain the equipment validation program and review all validation documents in the validation lifecycle to ensure compliance
  • Review and approve deviation/non-conformance/change control/CAPA (events) reports and records from validation/qualification perspective
  • Set up and maintain the validation periodic review program, including setting up the periodic review plan, performing periodic reviews and supporting re validation works from QA’s perspective
  • Support Engineering & Maintenance to set up a preventive maintenance and calibration program to ensure compliance with GMP requirements, and perform QA oversight on calibration and maintenance activities
  • Lead the inspection preparation and escort the inspections from the validation perspective
  • Contribute to set up the internal audit program and activate the internal audit plan
  • Support the setup and maintenance of other validation programs and activities including – process, method, cleaning, transportation, and becoming familiar with computer system validation strategy and approach

 

KNOWLEDGE, SKILLS AND ABILITIES

  • Degree in Life Sciences or relevant major
  • 3 - 5+ years validation relevant work experience in pharmaceutical or biologics manufacturing industry. Proven knowledge and experience in applying the risk based approach throughout the validation lifecycle
  • Strong knowledge of GMP and QMS principles
  • In-depth understanding of validation requirements in the regulation and guidance
  • Direct interaction with inspectors from major regulatory authorities
  • Knowledge and experience with aseptic processing is desirable
  • Excellent interpersonal skills, ability to work independently and in a team environment
  • Working efficiently with the ability to be innovative and identify creative solutions
  • High proficiency in MS Word/Excel and good writing skills

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!

HOW TO APPLY

Please apply through our online application system, found at: https://workforcenow.adp.com/jobs/apply/posting.html?client=NBILtd#


Posted: June 22, 2018
Closes: July 7, 2018
Email Address:
Company Info
Size:
51-200 employees
Industry:
Technology

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About New B Innovation Ltd.

Established in 2007, head quartered in Hong Kong, New B Innovation Canada (NBI) is committed to providing innovative products to fulfill medical needs following Good Manufacturing Practices (GMP) i...