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Quality Assurance Associate in Toronto REGN218, Canada

We are hiring a Quality Assurance Associate for our client a successful pharmaceutical company.



About this role

Responsibilities

  • Responsible for handling Customer Complaints for products manufactured by CMOs according to the Established process.
  • Tracks investigation progress by CMO
  • Reviews CMO Investigation Report to ensure that complaint was satisfactorily investigated and adequate CAPA identified.
  • Closes complaints and sends out Response Letter to complainants.
  • Responsible for the preliminary assessment for Release of batches manufactured by CMOs
  • Responsible for ensuring that all supporting documents are received and compliant to enable batch release.
  • Liaise with CMOs for any incomplete information and/or missing documents.
  • Reviews vendor Certificate of Analysis to confirm that product complies with approved product specifications.
  • Reviews vendor Certificate of Manufacture to confirm that product has been manufactured, packaged/labelled, tested and stored in accordance with vendor master production documents.
  • Reviews any non-conformance reports to ensure that incidents were satisfactorily investigated and to confirm that the batch to be released has not been adversely impacted.
  • Prioritizes the release of batches as per business needs.
  • Communicates the release of batches to all relevant personnel.
  • Supports additional activities as assigned by Management for internal audits, GMP inspections, etc.
  • Consolidates the CMO Change Control Management process.
  • Administers and manages incoming change controls for CMO-initiated changes to assure regulatory compliance.
  • Oversees CMO APR schedule and tracking.
  • Consolidates the information from internal functions with CMO to ensure compliance to regulatory requirements
  • Consolidates and trends CMOs Key Performance Metrics.
  • Generates periodic reports, highlighting trends and recommendations for management review.
  • Supports in the development of SODs to ensure efficient monitoring and surveillance of Quality oversight.
  • Updates and maintains the Quality database for vendors.
  • Responsible for updating and maintaining Product Specification and Product Compliance Files (PCF/PSF) for all investigational and commercial products.
  • Maintains and updates Quality Agreements and arrange for review, approval, courier, tracking and filing upon receipt of approved Quality Agreements from vendors.
  • Participate in QA compliance initiatives including initiation and revision of Standard Operating Documents.
  • Create trend reports for CMO issues such as complaints, deviations, excursions and documentation errors as required.
  • Initiate Deviation reports and follow-up with investigator on completion of deviation.
  • Perform initial review of deviations, complaints reports and audit responses.
  • Create and maintain QA spreadsheets for audits, stability data, batch (es) released (commercial and investigational), Quality Performance Indicators (includes audits, complaints, etc.).
  • Maintain stability spreadsheets for investigational and commercial products to ensure all stability reports are available as per commitments to regulatory agencies.
  • Schedule meetings and teleconferences, draft minutes for circulation to all attendees, assists with presentations.
  • Recruits, trains, develops and manages effectively the ongoing performance of their direct reports


About you

Requirements

  • Bachelor of Science / Community College Diploma in RA/QA /University degree (or equivalent) in Life Sciences or in a related discipline.
  • Minimum 4-5 years experience in QA, QC, Technical Operations or Regulatory Affairs within the pharmaceutical industry, preferred.
  • Must be familiar and knowledgeable with Canadian GMP, cGMP and EU regulations, and quality requirements as per other international regulations.
  • Detail orientated and accurate.
  • Strong verbal and written communication skills.
  • Excellent organizational skills and ability to manage time effectively.
  • Ability to manage multiple tasks simultaneously.
  • Excellent interpersonal skills and ability to relate well to internal and external customers.
  • Proficient with Microsoft Office (Word, Excel, Power Point and Access).


What we offer

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort let us match you to your ideal position.




About us

Brunel has a reputation for working with some of the best in the business. Thats what we continually strive for. Over 40 years, weve created a global network of interesting clients and talented individuals working together through a vast array of services.

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