Microbiology Laboratory Manager

4 weeks ago

Candiac, Quebec, Canada Pharmascience Full time

As a key member of the Pharmascience team, the Microbiology Laboratory Manager plays a critical role in ensuring the quality and compliance of our products. Reporting to the Head of Quality and Compliance, this position is responsible for planning, organizing, and directing the activities of the microbiology laboratory, supporting our three manufacturing plants.

Key Responsibilities:

  • Under the supervision of the Head of Quality and Compliance, the manager ensures the daily management of the microbiology laboratory activities for the 4 work shifts.
  • Reviews and approves new microbiological methods, validation reports, and protocols to ensure compliance with regulatory requirements.
  • Develops and maintains environmental monitoring programs within manufacturing sites, ensuring the implementation and monitoring of trend analysis systems.
  • Reviews and assesses the impact of change requests on the microbiological quality of products, raw materials, components, environment, equipment, and systems.
  • Participates in the development of investigations related to environmental monitoring, product analysis, and laboratory activities.
  • Reviews procedures related to environmental monitoring and microbiology activities, ensuring compliance with regulatory requirements.
  • Develops and maintains documentation and systems related to activities under their responsibility, including verification of laboratory data and approval of results in LIMS.
  • Participates in establishing departmental budgets and coordinates the hiring process of staff under their supervision.
  • Coordinates, supervises, and controls the activities of staff under their responsibility, ensuring the achievement of defined objectives.

    Human Resources Management:

    • Hires and trains staff to ensure the development of a skilled and motivated team.
    • Manages, motivates, and develops team members to achieve defined objectives, ensuring the success of the microbiology laboratory.
    • Evaluates the performance of employees under their responsibility based on annual performance objectives.
    • Maintains workforce levels to meet corporate objectives, ensuring the effective management of the microbiology laboratory.

      Skills, Knowledge, and Abilities:

      • Has in-depth knowledge of Canadian, European, and American Good Manufacturing Practices (GMP).
      • Has in-depth knowledge of microbiology requirements and techniques for manufacturing sterile and non-sterile dosage forms based on known pharmacopeias.
      • Has in-depth knowledge of analytical validation of microbiological methods.
      • Has the ability to manage priorities, meet tight deadlines, and ensure follow-ups.
      • Has good people management skills and excellent mastery of French and English, both oral and written.
      • Has mastery of the MS Office suite and Microsoft Project, which would be an asset.

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