About Us
Regulatory Solutions Inc. (RSI) is a pharmaceutical regulatory affairs and quality compliance consulting firm with a proven track record spanning over two decades. Our expertise lies in securing Canadian regulatory approvals and assuring quality compliance for pharmaceutical drugs, natural health products, and medical devices. At RSI, we cultivate a dynamic work culture that encourages innovation and high performance in a fun and fast-paced environment. RSI is constantly looking for great people to contribute to our growing business. We believe in empowering our employees by giving them the freedom to raise new ideas and encourage decision making in an environment that fosters growth and development.
About the Role
The Senior Quality Compliance Associate will be responsible to ensure that RSI, its affiliate companies, and their clients comply with quality assurance principles and GMP requirements of Health Canada. This position is responsible to support the importing, distributing, and wholesaling, of multiple dosage forms for prescription and OTC products, biosimilars, and natural health products, including sterile products. The candidate will be a self-motivated, energetic and a resourceful individual who will work closely with the internal team and external stakeholders to support the quality assurance activities.
Specific Responsibilities
- Assure that all GMP related documentation, analysis and relevant activities are in conformance with Canadian GMPs, regulatory filings and with client procedures
- Support submission activities and coordinate product launches as they relate to quality
- Conduct audits and coordinate self-inspections
- Support the maintenance of client master files, including API specifications, analytical methods, finished product specifications, test methods, analytical validation, process validation, stability
- Handle the investigation of customer complaints, CAPAs, deviations and investigations
- Respond to customer complaints and perform complaint trending
- Handle finished product releases, and coordinate testing to external labs
- Oversee the stability and annual confirmatory testing program
- Conduct annual product reviews and annual batch record reviews
- Manage change controls and deviations
- Prepare and update Standard Operating Procedures (SOP)
Required Qualifications
- Bachelor of Science degree in a relevant scientific field (e.g. chemistry, microbiology, or other physical sciences)
- Minimum 7 to 10 years direct Canadian pharmaceutical QA or QC role for importation and distribution of pharmaceutical drug products
- Pharmaceutical Regulatory Affairs and/or Quality Assurance certificate program is an asset
- Canadian non-prescription drug, medical device, natural health products, and cosmetics experience is an asset
Required Skills
- Working knowledge in the quality systems for the pharmaceutical industry, natural health products and medical devices
- Working knowledge of aseptic quality assurance, quality control and environmental monitoring
- Ability to work collaboratively in a professional and effective manner
- Ability to foster good working relationships with clients and Health Canada
- Ability to review lab test results, analytical data and reports, with strong investigation and problem-solving skills
- Experience in using computer programs (MS Word, Excel, and PowerPoint)
- Clear communication skills both oral and written
- Excellent attention to detail and organizational abilities
- Resourceful, energetic, and self-motivated
- Sense of urgency, results and performance-driven
- Strong leadership skills including the ability to manage and prioritize multiple tasks
- Ability to keep tight deadlines and work under pressure
- Flexibility and ability to adapt to change
- Diplomacy in establishing and maintaining interpersonal relationships
Benefits Offered:
- Competitive Benefits Package
- Learning and Development Opportunities
If you meet these qualifications and are interested in joining our team, please submit your resume to info@regulatorysolutions.ca.
At RSI, we value diversity and inclusion and are committed to creating an equitable workplace for all. We appreciate all applicants' interest in this position; however, only those being considered for an interview will be contacted.
Remuneration is competitive and will be based on qualifications and experience.
