Validation Specialist, Quality Assurance
ABOUT THE COMPANY
New Beta Innovation Canada Limited (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.
Reporting to the QA Manager, the incumbent will be responsible to perform QA oversight on validation and qualification activities.
- 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
- Review and maintain CSV and IT infrastructure and SOPs and policies, review IT infrastructure qualification documents
- Review software validation documents for Production process equipment, QC analytical instruments, spread sheets, and other NBICA’s electronic systems.
- 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, computer system validation
- Other related tasks as required.
KNOWLEDGE, SKILLS AND ABILITIES
- Degree in Life Sciences or relevant major
- 2 - 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
- Good understanding of GAMP 5 and Annex 11
- 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
- Strong sense of pride in ownership of, and quality of work
- 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!