Senior Associate, QA (R&D and Vendor Management) - Brampton East, Ontario Canada - 38349


Job #: 38349
Title: Senior Associate, QA (R&D and Vendor Management)
Job Location: Brampton East, Ontario - Canada
Employment Type:
Salary: contact recruiter for details
Employer Will Recruit From: Local
Relocation Paid?: NO


- Permanent Position

-8% bonus with Salary

-Full Benefits


Job purpose


Perform review of R&D GMP documentation and audits of the R&D GMP areas to ensure compliance to cGMP’s and SOP’s.    Establish and maintain the GMP and SOP training program for R&D personnel.  Support the Vendor Management Program in sourcing and assessment of new Raw Materials for R&D projects (APIs, Packaging Components and Excipients). Ensure effective and timely collaboration with R&D teams in support of R&D project objectives and timelines.



Duties and responsibilities


  • Review R&D GMP documentation for adherence to the GMP regulations and SOP’s
  • Periodically audit R&D GMP activity areas for compliance to cGMP’s and SOP’s.
  • Approve R&D manufacturing batch documents for validation, exhibit and clinical GMP batches.
  • Approve executed batch documents: (MF and PWOs), RMs, Packaging Components, Packaged Product COAs and Clinical COAs.
  • Manage the Training Program for R&D.  Develop and maintain employee specific training curriculums.
  • Revise/review SOPs and Forms for biennial reviews.
  • Prepare for Pre-Approval Inspections (PAI’s) and audit all data for projects identified for the inspection.
  • Administer R&D Change Control System and R&D electronic documents: SOPs, Testing methods, forms, specifications.
  • Foster strong relationships with key Pharma and/or Private Label customers and Vendors.
  • Interact and provide feedback to Pharma and Private Label customers and Vendors concerning all quality systems, change control notifications, product environments and laboratory results.
  • Prepare and maintain Quality Agreements.
  • Respond to customer and vendor queries and notifications within the scope of the quality agreement or SOP.
  • Onboard of new contract manufacturers and maintain approved contract manufacturers through processing, review and assessment of change controls, specifications, master documents and quality agreements.
  • Lead and/or Participate in Recall activities.
  • Participate in and/or lead Non-Conformance Investigations as related to Customers or Vendors.
  • Perform risk assessments (as needed) for material/component/vendor related issues.
  • Evaluate Vendor performance to determine initial approval and continued status.




  • Minimum of B.Sc. Chemistry or other associated discipline.
  • 5 - 7 years’ experience in Quality Assurance/Quality Compliance experience in the pharmaceutical industry environment. 
  • Sound knowledge of R&D processes applicable to Pharmaceutical Industry.
  • Thorough knowledge and understanding of the USP, BP, Ph.Eur. test requirements, GMP-s, as well as FDA, HC and ICH guidelines with regards to GMP.
  • Particularly good attention to detail.
  • Ability to work independently, with minimal supervision.
  • Good organizational skills and multi-tasking ability to meet R&D and Vendor management   deadlines and objectives.
  • Excellent written and verbal communication skills.
  • Ability to manage internal and external requirements.
  • Strong problem-solving skills with ability recommend and implement strategies towards enhancing the quality standards of the department and facility.
  • Evaluation of customer’s requests without divulging company confidential information

University - Bachelor's Degree/3-4 Year Degree


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