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Microbiology Laboratory Manager

2 months ago

Candiac, Quebec, Canada Pharmascience Full time

Lead a Team of Experts in Microbiology at Pharmascience

Reporting to the Head of Quality and Compliance, Candiac site, the Microbiology Laboratory Manager plays a pivotal role in ensuring the highest standards of quality within our manufacturing operations. You will oversee the daily activities of the microbiology laboratory, supporting three Pharmascience manufacturing plants (non-sterile and sterile).

As an expert in analytical techniques and environmental monitoring, you will collaborate with various stakeholders, including customers, partners, external laboratories, and regulatory bodies.

Responsibilities
  • Laboratory Management: Oversee the daily operations of the microbiology laboratory across four work shifts, ensuring efficient workflow and adherence to established protocols.
  • Method Development & Validation: Review and approve new microbiological methods, validation reports, and protocols, contributing to the continuous improvement of our analytical capabilities.
  • Environmental Monitoring Programs: Develop and maintain comprehensive environmental monitoring programs across manufacturing sites. Implement robust trend analysis systems to identify potential risks and ensure a contamination-free environment.
  • Change Impact Assessment: Evaluate the impact of proposed changes on microbiological quality, encompassing products, raw materials, components, equipment, and systems.
  • Investigation & Root Cause Analysis: Participate in investigations (OOS, deviations) related to environmental monitoring, product analysis, and any events impacting the microbiology laboratory's activities.
  • Documentation & Systems Management: Develop and maintain documentation and systems for all activities under your responsibility, including verification of laboratory data and approval of results within LIMS.
Human Resources Management
  • Recruitment & Training: Hire and train staff members to ensure a skilled and motivated team.
  • Team Development & Motivation: Manage, motivate, and develop team members to achieve defined objectives and foster a collaborative work environment.
  • Performance Management: Evaluate the performance of employees under your supervision based on established annual performance objectives.
  • Workforce Planning: Maintain appropriate workforce levels to meet corporate objectives and ensure operational efficiency.
Skills & Qualifications
  • In-depth knowledge of Canadian, European, and American Good Manufacturing Practices (GMP).
  • Comprehensive understanding of microbiology requirements and techniques for manufacturing sterile and non-sterile dosage forms, aligned with recognized pharmacopeias (USP, EP, BP).
  • Expertise in analytical validation of microbiological methods.
  • Proven ability to manage priorities, meet tight deadlines, and ensure effective follow-up on tasks.
  • Strong people management skills with a focus on team development and motivation.
  • Excellent mastery of French and English, both written and spoken.
  • Proficiency in the MS Office suite; experience with Microsoft Project is an asset.