Quality Assurance Operations Manager

2 weeks ago

Montreal, Quebec, Canada Pharmascience Full time

As part of the Royalmount Site team at Pharmascience, the Quality Assurance Operations Manager will play a critical role in ensuring the highest quality standards are met in all aspects of quality assurance, investigations, and operations floor support.

Key Responsibilities:

  • Lead quality assurance investigations, complaints, and CAPA to operations, ensuring seamless collaboration and effective resolution.
  • Define the objectives of quality assurance investigations and floor support to operations, aligning with corporate goals and objectives.
  • Plan and organize work to achieve targeted objectives, leveraging expertise in quality management procedures, standards, and concepts.
  • Ensure interpretation and implementation of GMP compliance, consulting, training, and support services to maintain and improve quality.
  • Track priorities and compile results (KPI), providing actionable insights for continuous improvement.
  • Provide support during regulatory and client inspections, ensuring compliance and excellence.
  • Contribute to the development of performance indicators for the Royalmount site, driving performance and excellence.
  • Assist in the replacement of QA Managers and the Head of Quality and Compliance RMT site, ensuring continuity and expertise.
  • Approve investigations and CAPA, ensuring thoroughness and compliance.
  • Review and approve procedures, ensuring alignment with GMP standards and company policies.
  • Ensure investigation release follow-up to meet release deadlines, maintaining a focus on quality and timelines.
  • Manage, motivate, and develop team members to achieve defined objectives, fostering a culture of excellence and quality.
  • Evaluate employee performance according to annual performance objectives, ensuring alignment with company goals.

Requirements:

  • Deep knowledge of Canadian, US, and European GMP and ICH standards.
  • Expertise in quality management procedures, standards, programs, and concepts.
  • Experience in multifunctional teamwork and project management.
  • Excellent quality of verbal and written communication with stakeholders, both internal and external.
  • Strong planning and organizational skills.
  • Ability to identify and solve problems, driving continuous improvement.
  • Rigor and attention to detail, ensuring excellence in all aspects.
  • Ability to make decisions, aligning with company goals and policies.
  • Knowledge of Microsoft Office suite software.
  • Fluent in English and French, with the ability to communicate effectively with regulatory authorities, suppliers, and clients.

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