Division: Pharma – CRO

Do YOU want to join one of Canada’s fastest-growing Contract Research Organizations (CRO) that is dedicated to providing quality and service excellence to our pharmaceutical and biotechnology clients and their customers?

At Calian CRO, we continually strive to expand our knowledge base and experience by hiring talented people to further our remarkable growth. Our aim is to find the right people for the right roles to deliver services in line with industry best practices.

Our high-growth organization is seeking an experienced and professional CMC QA Specialist to join our dynamic team on behalf of our client. This is a part-time position (24 hours/week). The candidate may be located remotely anywhere in Canada.

If YOU are passionate about GMP and have strong leadership skills, we would love to hear from YOU!

Project Summary

The CMC QA Specialist will work flexibly across a number of markets for our client’s drug product program with an emphasis on managing outsourced analytical methods, data and stability programs for the cGMP API manufacturing. They are an expert internally in the principles and application of quality assurance and compliance and coordinates GMP activities in support of clinical and commercial Drug Product disposition.

Accountabilities

• Oversee the generation, review, and archival of documents used to support Good Manufacturing Practice manufacture of Final Product.
• Review and release raw materials, intermediate products and finished products.
• Perform review and approval of OOS, deviations, nonconformance, and investigation as required
• Design and execute stability programs for critical and custom raw materials, API and drug products.
• Monitor and compile stability data and provide justifications/reports for retest dates and shelf-life.
• Organize and file internal and external QC data, protocols and reports
• Perform internal and external audits as assigned
• Participate in CMO audits and site visits as required
• Coordinate and/or conduct GMP training
• Generate, publish, and manage quality systems metrics to drive continuous improvement
• Coordinate Corrective Action/Preventive Action (CAPA), Out of Specification (OOS), deviations, nonconformance, and investigations.
• Assist with revising and developing standard operating procedures
• May perform additional duties as required.

Competencies:

• Motivated and experienced self-starter.
• Ability to independently and with cross-functional teams representing Quality.
• Ability to communicate effectively across all organizational levels.
• Ability to evaluate quality matters and make decisions using a risk-based approach.
• Strong knowledge and understanding of cGMP and of the Canadian and EU regulatory environments.
• Proven experience supporting GMP manufacturing either via experience in manufacturing and /or experience. providing QA operational support of GMP manufacturing.
• Proficient with Microsoft Office tools, especially Excel.
• Technical writing.

Required Experience

• Master’s degree with 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field with minimum 5 years of relevant work experience, or relevant comparable background.
• Experience in cGMP environment within relevant Quality Assurance/Compliance functions.
• Experience providing QA support and oversight of GMP manufacturing operation including batch release.
• Experience with drug product development and manufacturing with proficient knowledge of the following in a pharmaceutical setting:
• • cGMP’s and associated CMC regulatory considerations
  • Continuous manufacturing.
  • Experience successfully leading event investigations, Root Cause Analysis and CAPA
• Excellent writing/communication skills.
• Training experience a plus.

Working Conditions and / or Job Requirements:

• Must possess mobility to work in a standard office setting and to use standard office equipment,
• including a computer (finite movements such as typing and other office functions)
• Requires mental stamina to maintain attention to detail despite interruptions, and vision to read printed
• materials and a computer screen.
• Ability to travel is required.