Job Summary
We are seeking a dedicated Biopharma Regulatory Affairs / Quality Assurance (QA) Analyst to join a dynamic team. This role is pivotal in ensuring compliance with Health Canada regulatory standards and maintaining the highest quality levels across our client's biopharmaceutical manufacturing processes. The successful candidate will oversee regulatory compliance, quality inspection activities, support data collection efforts, and contribute to continuous regulatory and quality management improvements. This position offers an opportunity to play a vital role in advancing innovative biopharmaceutical products while upholding rigorous quality assurance and regulatory compliance standards.
Duties
- Conduct comprehensive quality and regulatory inspections throughout the manufacturing process to verify adherence to regulatory and internal standards.
- Collect, analyze, and interpret data related to product quality, process performance, and compliance metrics.
- Support the development and implementation of quality management systems (QMS) aligned with industry best practices.
- Collaborate with manufacturing teams to identify root causes of quality issues and recommend corrective actions.
- Maintain detailed documentation of inspection results, analysis reports, and compliance records for audit readiness.
- Assist in the review and approval of manufacturing batch records, validation protocols, and change control documentation.
- Participate in internal audits and support external regulatory inspections by providing accurate documentation and insights.
- Contribute to ongoing training initiatives related to quality standards, regulatory requirements, and data collection procedures.
- Support continuous improvement initiatives by analyzing trends in quality data and proposing enhancements.
Qualifications
- Bachelor's degree in Life Sciences, Biotechnology, Chemistry, or a related field; advanced degrees are a plus.
- Proven experience in regulatory and quality inspection, analysis skills, and quality management within the biopharmaceutical or pharmaceutical industry.
- Strong understanding of QA/QC principles, regulatory guidelines (such as HC, FDA, EMA), and manufacturing processes.
- Excellent attention to detail with strong analytical and problem-solving skills.
- Effective communication skills for collaboration across multidisciplinary teams.
- Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
- Ability to adapt quickly to evolving regulatory requirements and industry standards.
This position is an excellent opportunity for professionals committed to ensuring product excellence through meticulous regulatory and quality assurance practices. We welcome candidates eager to contribute their expertise towards advancing safe and effective biopharmaceutical innovations.
Suitable candidates must have a background in both RA and QA.
Pay: $60,000.00-$72,000.00 per year
Benefits:
- Casual dress
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- On-site parking
- Paid time off
- Vision care
Application question(s):
- Do you work in regulatory affairs as well as quality? This is essential.
- Have you worked in a biopharma/pharma related industry?
Location:
- Toronto, ON M5H 2N1 (required)
Work Location: In person
