Investigator and Qualified Person Responsible (QPR) for Operations - #447916

Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence.

We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future.

We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.

Primary Objective

The Investigator and Qualified Person Responsible (QPR) is responsible for conducting investigations following deviations, non-conformities, complaints, or quality anomalies, as well as managing controlled substances and precursors. They identify root causes, propose corrective and preventive actions (CAPA), and contribute to the continuous improvement of the quality system.

MAIN RESPONSIBILITIES:

• Work in close collaboration with experts from various departments in the plant and provide support in writing, investigating, and following up on non-conformities initiated by the plant.
• Conduct investigations using a defined methodology (5M - Ishikawa, 5 Whys).
• Review the evidence provided by subject matter experts against the initial hypotheses, validate the hypotheses, and determine the probable root cause of the non-conformity in collaboration with experts.
• Document risk assessments and potential quality impacts related to the deviation.
• Determine, with experts, the appropriate corrective and preventive actions (CAPA) or change requests (CR) based on identified probable causes to prevent recurrence.
• Participate, when applicable, in continuous improvement projects.
  
  

Controlled Drugs and Precursors Compliance:

• Enforce regulations governing our role as a distributor of controlled drugs and precursors.
• Understand laws regulating controlled drugs and other substances.
• Maintain compliance with licenses for controlled drugs and precursors granted by Health Canada.
• Support the organizations production needs while ensuring compliance with controlled substances regulations.
• Be responsible for the work of QPR substitutes.
• Lead inspections related to controlled drugs and precursors conducted at our site.
• Coordinate with supplier QPRs for all shipments or receipts of raw materials, bulk products, finished products, reference standards, or others.
• Coordinate with client QPRs for all shipments or receipts of raw materials, bulk products, finished products, reference standards, or others.
• Request import and export permits from Health Canada.
• Maintain updated transaction records for products entering and leaving areas designated for controlled drugs and precursors.
• Maintain inventories of analysis samples, stability samples, and official samples in their designated storage areas.
• Inform QPRs/substitute QPRs of changes affecting tasks associated with controlled drugs and precursors.
• Prepare monthly and annual reports to be submitted to Health Canada.
• Maintain documentation and records in proper order.
• Coordinate with suppliers handling the destruction of controlled drugs and precursors.
  
  

REQUIREMENTS AND REQUIRED COMPETENCIES:

Bachelors degree in a science-related field

Minimum 5 Years Of Experience In The Pharmaceutical Industry

At least 3 years of experience in Quality Assurance, specifically related to non-conformity investigations, preferably in a senior investigator role

Proven knowledge of Canadian, U.S., and international GMP regulations

Excellent knowledge and understanding of pharmaceutical production processes

Mastery of investigation tools (Ishikawa, 5 Whys, FMEA, etc.)

Excellent written and verbal communication skills in both French and English

The masculine is used in this publication without prejudice for the sake of conciseness.

Bausch Health is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.

Bausch Health is an EEO/AA employer M/F/D/V.