GCP Quality Assurance Manager/ Senior Associate - Home Based

  • BSc with 5+ years' experience in pharma
  • Knowledge of GCP compliance, including audits and CAPAs
  • Senior Associate and/or supervisory experience preferred

Kelly Scientific Resources believes in relationships, not transactions. That's why we're committed to successfully matching job seekers with the best employers across Canada and around the world. We fill positions from entry level to senior management, on a temporary or permanent basis. Whether your specialty is Science, Engineering, IT, Finance, Marketing, Manufacturing, Contact Centre or Business Administration, we'll work with you to understand your likes, dislikes, goals and ambitions, and present you with opportunities that meet your needs. See what we have to offer.
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Kelly Services (Canada) Ltd., is committed to providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
QUALITY ASSURANCE MANAGER/ SENIOR ASSOCIATE - HOME BASED
Roles & Responsibilities:
  • Provide input on all procedures to ensure compliance with applicable GCP and ICH regulations (E6(R2))
  • Participates in the QMC as required and has oversight of the document management system and training records.
  • Leads all departments to ensure company and its CRO/clinical sites are in a state of inspection readiness, particularly as related to activities associated with Pre-Approval Inspections.
  • Provide GCP compliance oversight of internal systems and processes as well as those of CROs, vendors, and clinical investigator sites.
  • Plans and conducts internal GCP audits. Manages all audit findings and resulting CAPAs.
  • Completes clinical site audits and vendor audits and manages all resulting CAPAs
  • Coordinate the continuous improvement of systems to assure the quality of trials
  • Develops QA procedures for the GCP Quality Management System and educates staff on its function and importance
  • Identifies and monitors deviations and leads the CAPA management process for GCP issues.
  • Prepares QA memos, devotions or NTF for GCP issues as required.
  • Completes required SOP training as identified by in training matrix
  • Ensures that QA GCP duties are carried out promptly, effectively and efficiently

Requirements:
  • University degree in science or college diploma, combined with a minimum of 5+ years of relevant experience in the pharmaceutical industry
  • Minimum of three (3) years in a supervisory/management role
  • Excellent knowledge of Good Clinical Practices (GCP) and technical knowledge of pharmaceutical processes, as well as of quality control and quality assurance concepts
  • Knowledge of the international guidance's and requirements (ICH, FDA, EMEA)
  • Experience in regulatory affairs would be an asset
  • Excellent command of English language both written and spoken
  • Knowledge of Microsoft applications
  • Senior Associate and/or supervisory experience preferred

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About Kelly Services (Canada), Ltd.

We connect great people with great companies. Because what's next matters. As a global leader in providing workforce solutions, Kelly offers world-class staffing including temporary, temporary-to-hire, and full-time placements across many professions for companies of all sizes. 
Kelly founded the temporary staffing industry in 1946, and has maintained a leadership position for more than 70 years of sustained innovation that is based on a valuable premise: we invest in people. Today that same focused expertise benefits our clients wherever they operate around the globe-in a growing number of specialized fields from office and administration, manufacturing and logistics, call centre, engineering, finance, science - and many others. We continue to meet the evolving challenges of workforce flexibility with staffing solutions tailored to your precise business needs, both locally and worldwide.

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