Quality Control Compliance Specialist / Spécialiste en conformité du contrôle de la qualité Job in Core Healthcare

Quality Control Compliance Specialist / Spécialiste En Conformité Du Contrôle De La Qualité

Montréal, QC, CA, Canada

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Job Description

Oversee and sustain a comprehensive environmental monitoring (EM) program to ensure ongoing regulatory compliance. Evaluate and update EM procedures regularly to reflect changes in regulatory requirements and industry best practices. Conduct routine inspections and compliance audits in controlled manufacturing zones to verify adherence to SOPs and relevant regulations. Keep abreast of the latest developments and revisions in environmental monitoring standards. Contribute to and assist with EM system requalification activities to maintain validated conditions. Provide expert guidance on aseptic processes and environmental control measures across teams. Analyze environmental monitoring data to identify trends, initiate corrective measures, and ensure consistent environmental integrity. Perform risk assessments related to EM operations and document validation activities and system performance.

Qualifications and Experience:

Bachelor's degree in Microbiology, Life Sciences, or a related field, or equivalent hands-on experience. At least 5 years' direct experience with environmental monitoring and microbiological techniques in pharmaceutical or healthcare manufacturing environments. Strong familiarity with pharmaceutical processes including validation, manufacturing, packaging, and quality testing. Deep understanding of cGMP regulations as enforced by Canadian, U.S., and European authorities. Excellent communication, organizational, and teamwork skills with strong analytical capabilities. In-depth knowledge of sterile production environments and compliance-focused methodologies.
Job Type: Full-time

Schedule:

Monday to Friday
Work Location: In person

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