Manager, Microbiology Laboratory

Job title:

Manager, Microbiology Laboratory

Company

Pharmascience

Job description

Description :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). The manager acts as an expert (analytical techniques or environmental monitoring) during various interactions with customers, our partners, external laboratories and during regulatory inspections.Responsabilities and Tasks :

• In support of the supervisor, the manager ensures the daily management of the activities of the microbiology laboratory for the 4 work shifts.
• Reviews and approves new microbiological methods, microbiological validation reports and protocols.
• Develops and maintains environmental monitoring programs within manufacturing sites. And ensures the implementation and monitoring of appropriate trend analysis systems.
• Reviews and assesses the impact of change request that may affect the microbiological quality of products, raw materials, components, environment, equipment and systems.
• Participates 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.
• Reviews procedures related to environmental monitoring and microbiology activities.
• Develops and maintains documentation and systems related to activities under his/her responsibility (including verification of laboratory data and approval of results in LIMS).
• Participates in establishing departmental budgets.
• Participates in the hiring process of staff under his/her supervision.
• Coordinates, supervises and controls the activities of the staff under his/her responsibility.

Human resources management :

• Hires and trains staff
• Manages, motivates and develops team members to achieve defined objectives
• Evaluates the performance of employees under his/her responsibility based on the annual performance objectives set.
• Maintains workforce levels to meet corporate objectives.

Skills, knowledge and abilities :

• 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.

Education : BachelorExperience : 0 years: Field experience that includes practicing the requirements for manufacturing sterile and non-sterile products.
0 years: A minimum of 5 years of supervisory experience.
0 years: Five years experience in microbiology in a pharmaceutical company

Expected salary

Location

Canada

Job date

Wed, 25 Sep 2024 07:36:17 GMT

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