Manager Quality Operation

1 week ago

Montreal, Canada Pharmascience Inc. Full time

Under the authority of the Head of Quality & Compliance of the Royalmount Site, you will be responsible for organizing, managing and controlling all activities related to quality assurance in connection with the investigations and complaints initiated at the RMT site for CAPA and operations floor support.

RESPONSABILITIES & DUTIES:

  1. Lead the quality assurance investigations, complaints, CAPA and floor support to operations.
  2. Define the objectives of the quality assurance investigations and floor support to operations.
  3. Plan and organize the work in order to achieve the targeted objectives.
  4. Insure interpretation of GMP compliance, consulting, training and any other support services to maintain and improve quality.
  5. Track priorities and compile results (KPI).
  6. Can be asked for support during regulatory and client inspections.
  7. Participate in the development of performance indicators for the Royalmount site.
  8. Can be asked to replace QA Managers as well as the Head of Quality and Compliance RMT site.
  9. Approve investigations and CAPA.
  10. Review and approve procedures.
  11. Ensure investigation release follow-up in order to meet the release deadlines.
  12. Manage, motivate and develop team members in order to achieve defined objectives.
  13. Evaluate employees’ performance according to the annual performance objectives set.
  14. Maintain a workforce level in order to achieve corporate objectives.

SKILLS, KNOWLEDGE & ABILITIES:

  1. In-depth knowledge of Canadian, US and European good manufacturing practices (GMP) and ICH standards.
  2. Expertise in the implementation of quality management procedures, standards, programs and concepts.
  3. Experience in multifunctional teamwork and project management.
  4. Excellent quality of verbal and written communication between the various stakeholders both internally and externally of the company.
  5. Excellent planning and organizational skills.
  6. Ability to identify and solve problems.
  7. Rigor and attention to detail.
  8. Ability to make decisions.
  9. Knowledge of Microsoft Office suite software.
  10. Fluent in English & French (oral & written), since the role requires interaction with regulatory authorities, suppliers and clients located outside the province of Quebec.
Qualifications

Required:

Bachelor or better in Science.

Experience

Required:

3 years: Experience in team supervision and management.

5 years: Experience in a similar position in the pharmaceutical industry.

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