Microbiology Compliance Specialist / Spécialiste de la Conformité en Microb at Core Healthcare
Montréal, QC, Canada -
Full Time


Start Date

Immediate

Expiry Date

25 Oct, 25

Salary

0.0

Posted On

25 Jul, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Manufacturing, Communication Skills, Packaging, Microbiology, Life Sciences

Industry

Pharmaceuticals

Description

REQUIRED QUALIFICATIONS & EXPERIENCE:

  • Degree in Microbiology, Life Sciences, or a closely related discipline, or equivalent practical experience in the field.
  • A minimum of 5 years’ hands-on experience with EM practices and microbiological testing in pharmaceutical or regulated healthcare environments.
  • Solid knowledge of pharmaceutical production, including equipment validation, quality control, packaging, and manufacturing workflows.
  • Comprehensive understanding of cGMP requirements as outlined by Canadian, U.S., and EU regulatory bodies.
  • Strong interpersonal and communication skills, with the ability to work cross-functionally.
  • Proven expertise in sterile manufacturing and regulatory-compliant operational practices.
    Job Type: Full-time

Schedule:

  • Monday to Friday

Work Location: In perso

Responsibilities

ROLE SUMMARY:

Lead and maintain a robust environmental monitoring (EM) program to support regulatory adherence and ensure environmental control in manufacturing operations.

KEY RESPONSIBILITIES:

  • Manage the ongoing execution of the EM program, ensuring alignment with current regulatory standards.
  • Review and revise EM protocols regularly to incorporate regulatory updates and industry innovations.
  • Perform regular walkthroughs and inspections within classified areas to confirm compliance with SOPs and applicable regulatory frameworks.
  • Monitor and interpret emerging changes in EM regulations and industry guidance.
  • Support EM system requalification efforts to sustain validated manufacturing conditions.
  • Offer technical support and advice on aseptic operations and contamination control strategies.
  • Track and evaluate EM data trends to drive improvements and maintain a state of control.
  • Conduct risk assessments for EM-related processes and document performance against validation criteria.
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