Job Description

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?



Job Type


Part Time

1 year contract

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.

Position Overview

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) and the working hours could be anytime between 8am to 3PM EST between Monday - Friday The candidate may be located remotely anywhere in Canada.



The CMC QA Specialist will have a strong knowledge of Quality Assurance (QA) for commercialized products. They will work flexibly across several markets for our client's drug product program with an emphasis on managing QA aspects of outsourced manufacturing, packaging, testing and stability programs for the cGMP manufacturing of drug product. 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.



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

Responsibilities

Oversee the generation, review, and archival of documents used to support Good Manufacturing Practice Develop and maintain the Quality Management System.



Perform the generation, review, and archival of documents used to support Good Manufacturing Practice manufacture of Final Product.



Develop and maintain product release specifications.



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.



Review and treatment of Pharmacovigilance and MedInfo product quality complaints, inquiries and adverse events



May perform additional duties as required.

Qualifications

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.

Additional 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.