Microbiology Laboratory Manager
4 weeks ago
Under the authority of the Head of Quality and Compliance, Candiac site, the Microbiology Laboratory Manager is responsible for planning, organizing, and directing the activities of the microbiology laboratory supporting the three (3) Pharmascience manufacturing plants (non-sterile and sterile).
Key Responsibilities:
- Ensure the daily management of the activities of the microbiology laboratory for the 4 work shifts.
- Review and approve new microbiological methods, microbiological validation reports, and protocols.
- Develop and maintain environmental monitoring programs within manufacturing sites.
- Review and assess the impact of change requests that may affect the microbiological quality of products, raw materials, components, environment, equipment, and systems.
- Participate in the development of investigations (OOS, deviations) related to environmental monitoring, products analyzed by the laboratory, and for any event related to the activities of the microbiology laboratory.
- Review procedures related to environmental monitoring and microbiology activities.
- Develop and maintain documentation and systems related to activities under his/her responsibility.
- Participate in establishing departmental budgets.
- Participate in the hiring process of staff under his/her supervision.
Human Resources Management:
- Hire and train staff.
- Manage, motivate, and develop team members to achieve defined objectives.
- Evaluate the performance of employees under his/her responsibility based on the annual performance objectives set.
- Maintain workforce levels to meet corporate objectives.
Requirements:
- In-depth knowledge of Canadian, European, and American Good Manufacturing Practices (GMP).
- In-depth knowledge of microbiology requirements and techniques for manufacturing sterile and non-sterile dosage forms based on known pharmacopeias (USP, EP, BP).
- In-depth knowledge of analytical validation of microbiological methods.
- Ability to manage priorities, meet tight deadlines, and ensure follow-ups.
- Good people management skills.
- Excellent mastery of French and English, both oral and written.
- Mastery of the MS Office suite; Mastery in Microsoft Project would be an asset.
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