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Quality Assurance Operations Lead

2 months ago

Candiac, Quebec, Canada Pharmascience Full time

The role of the Quality Assurance Operations Lead at Pharmascience involves overseeing the implementation and maintenance of high-quality standards within the operational departments.

Responsibilities include monitoring Key Performance Indicators (KPIs) for quality systems, such as CAPA's and deviations, to ensure compliance with Good Manufacturing Practices (GMPs) and internal procedures.

The Quality Assurance Operations Lead actively participates in multi-functional teams addressing quality incidents, ensuring prompt resolution and implementing corrective actions.

In addition, the lead conducts reviews and approvals of minor and major deviation reports, INF /FOR/WI, and interfaces with other operational departments on matters of quality.

Furthermore, the Quality Assurance Operations Lead contributes to establishing and maintaining a culture of quality throughout Pharmascience's operational structure.

Main Responsibilities

  • Conduct internal audits of production floors and reception/sampling activities to verify adherence to GMPs and internal procedures.
  • Verify the application of GMPs, Health & Safety, and internal procedures, making recommendations and managing cases of non-conformity with responsible personnel.
  • Participate in determining immediate action requirements, including lot or partial lot inspections, and lot disposition, coordinating/performing inspections as needed.
  • Document actions and lot disposition information electronically in Trackwise and SAP.
  • Engage in discussions and facilitate cross-functional team engagement for production non-conformities, representing Quality in SWAT discussions and ensuring correct actions are performed from a quality and compliance perspective.
  • Categorize quality events and assure immediate actions are identified and adequate, supporting investigators and implementing effective CAPAs as required.
  • Support audits (client, regulatory, internal) as needed.
  • Monitor, report, and ensure respect of KPIs for Deviation and CAPA systems.

QA Support to Business

  • Actively participate in problem-solving and continuous improvement initiatives.
  • Prepare and/or participate in training activities.
  • Maintain Operational Quality Advisor team tools and files.
  • Monitor and ensure respect of departmental KPIs and objectives.
  • Support risk analysis and trending activities to ensure long-term compliance of operational activities with GMP.

Required Skills and Qualifications

  • Ability to make decisions and communicate them tactfully and diplomatically.
  • Strong problem-solving skills.
  • Proven coaching and leadership skills.
  • Analytical skills.
  • Thoroughness and rigor.
  • Observation skills.
  • Solid organizational skills.
  • Technical writing skills.
  • French and English oral & written (client and supplier audits).
  • Competent with MS Office, SAP.

Estimated salary: $70,000 - $100,000 per year, depending on experience and location. The role requires strong analytical and problem-solving skills, with the ability to work effectively in a team environment. If you possess these qualities and are passionate about quality assurance, we encourage you to apply.