Quality Assurance Associate

1 month ago

Fredericton, New Brunswick, Canada SUN PHARMA Full time
Job Summary

The Quality Assurance Associate is responsible for ensuring that all manufacturing processes are compliant with cGMP regulations. This involves identifying deviations, conducting investigations, and implementing corrective actions to prevent future occurrences.

Key Responsibilities
  • Conduct initial deviation investigations and identify root causes
  • Collaborate with Quality Engineers and QA Management to ensure thorough and complete investigations
  • Develop and implement corrective actions to prevent future deviations
  • Perform area assessments and ensure compliance with SOPs, Policies, and Procedures
  • Manage deviations, investigations, and preventive actions in Trackwise
  • Control materials for compliance purposes in SAP
  • Execute final release inspections of packaging lines
  • Perform acceptance sample analysis for validation and investigation support
  • Review and approve controlled documents
  • Communicate with customers to facilitate continuous process improvement
Work Environment

The Quality Assurance Associate will work in an office, lab, or manufacturing environment. The noise level is usually moderate.

Physical Requirements

The physical demands of this role include standing, walking, sitting, stooping, kneeling, crouching, crawling, pushing, and bending. The employee must be capable of bending and lifting up to 20 pounds and navigating office, lab, and/or plant floor working environments.

Education and Qualifications
  • Minimum of Bachelor's degree
  • Understanding of GMPs
  • Expertise in software applications such as MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, Acrobat Reader, TrackWise, or similar QMS, LMS (Learning Management System)
  • Knowledge of project management principles, practices, techniques, and tools
  • Strong interpersonal and communication skills
  • Strong organizational and time management skills
  • Self-starter with a hands-on approach and a can-do attitude
Experience
  • Minimum two years of experience within the pharmaceutical industry in a quality function role
  • Experience working in an international multicultural matrix organization

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