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Quality Assurance Coordinator (Contract)


Manufacturing / Operations
Pickering , Ontario

Quality Assurance Coordinator 


Contract End Date: June 30, 2020

Position Summary:

As part of the Quality Department, this position is responsible to perform quality assurance and compliance activities at a high accuracy level while maintaining company compliance with regulatory requirements. This position will perform a variety of tasks with minimal supervision and in accordance with current GMP's.

Responsibilities:

Perform product and material review/ release, deviations, AQLs, CAPAs. Make decisions related to product acceptance and market release, adhering to compliance

  • Propose CAPA and perform risk assessments
  • Represent Quality Team on Internal departmental meetings, acting as the liaison to coordinate implementation on required activities
  • Process All Types of Change Controls, Complaints, Metrics, Risk Assessments, Recalls
  • Support the introduction of new raw material and packaging components, internal manufacturing of a new product or external new products
  • Support Quality Assurance initiatives and Operation Excellence initiatives
  • Participate as an active member during Regulatory and Customer Audits
  • Perform External and Internal Audits
  • Initiate Audit Risk assessment and propose audit frequency
  • Perform Vendor Qualification based on supplier documentation
  • Initiate and revise Quality Technical Agreements
  • Gather Data, evaluate trends to perform Annual Product Review assessments as part of continuous product quality monitoring
  • Back up for Quality System Coordinator. Perform activities associated with filling, retrieval of documents, Stability Data gathering, upload of documentation, customer approvals, etc.

 

Qualifications:

  • University Degree required; Bachelor of Science preferred
  • One year of experience in a GMP environment, or graduate Co-op student with Pharmaceutical or GMP experience
  • Prior exposure to change management principles
  • Must have experience performing internal and external audits and have excellent report writing skills
  • Knowledge of Annual Product Review trending and statistical analysis
  • Sound knowledge of quality systems and performance tools (e.g. such as TQM, SPC, Process Maps, DMAIC, etc.)
  • Computer skills include proficiency in Word, Excel, and Access
  • Ability to multitask, prioritize and able to change prioritize as needed
  • Effective communication and teamwork attitude
  • Flexible mindset and receptive to learning opportunities

 

 

 

Purdue Pharma is an Equal Opportunity Employer. In accordance with the Accessibility for Ontarians with Disabilities Act, 2005 and the Ontario Human Rights Code, Purdue Pharma will provide accommodations to applicants with disabilities throughout the recruitment, selection and/or assessment process. If selected to participate in the recruitment, selection and/or assessment process, please inform Human Resources staff of the nature of any accommodation(s) that you may require.

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