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Laboratory QA Manager - Pharma GMP

Laboratory QA Manager - Pharma GMP

Pathogenia LabGreater Montreal Metropolitan Area, Canada
25 days ago
Job type
  • Full-time
Job description

Company Description

Pathogenia Laboratory is a leading analytical laboratory, certified to GMP by Health Canada. We specialize in delivering high-quality analytical testing services, ensuring compliance with regulatory requirements and supporting our clients in achieving their quality objectives.

Job Summary :

We are seeking a detail-oriented and experienced Quality Assurance (QA) Manager to lead our GMP program. The ideal candidate will oversee all aspects of quality assurance in compliance with GMP standards, ensuring laboratory operations meet regulatory and client expectations.

Key Responsibilities :

  • Manage and oversee the GMP Quality Assurance program, ensuring compliance with Health Canada regulations and guidelines.
  • Develop, implement, and maintain QA policies, standard operating procedures (SOPs), and quality systems.
  • Conduct internal audits, identify areas of non-compliance, and implement corrective and preventive actions (CAPA).
  • Oversee document control, including reviewing and approving quality-related documents such as test methods, validation protocols, and reports.
  • Monitor and evaluate laboratory operations for adherence to GMP standards.
  • Act as the primary contact during regulatory inspections and client audits, ensuring timely resolution of findings.
  • Train and mentor laboratory staff on GMP requirements and quality practices.
  • Collaborate with cross-functional teams to address quality issues and drive continuous improvement initiatives.
  • Prepare and present quality metrics and reports to senior management.
  • Stay updated on regulatory changes and implement necessary updates to maintain compliance.

Qualifications and Experience :

  • A Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, Microbiology, or a related field.
  • Minimum of 7 years of experience in quality assurance within a GMP-certified pharmaceutical analytical laboratory.
  • In-depth knowledge of Health Canada GMP guidelines and international quality standards.
  • Proven experience in managing regulatory inspections and client audits.
  • Strong leadership and organizational skills with a proactive approach to problem-solving.
  • Excellent communication skills to effectively liaise with internal and external stakeholders.
  • Proficiency in quality management systems and laboratory information management systems (LIMS).
  • Preferred Qualifications :

  • Certification in Quality Management or GMP (e.g., CQE, CQA).
  • Experience with method validation and technology transfer.
  • Familiarity with ISO 17025 standards.
  • What We Offer :

  • Competitive salary and comprehensive benefits package.
  • Opportunities for professional growth and development.
  • A collaborative and quality-focused work environment.