Senior Environmental Monitoring Specialist, GMP Compliance

3 weeks ago

Richmond Hill, Canada APOTEX Full time

About Apotex Inc.

Apotex Inc. is a global pharmaceutical company that produces high-quality medicines for patients worldwide. With almost 7,200 employees globally, the company operates in manufacturing, R&D, and commercial operations. Its products are accessible to over 75 countries globally.

Job Summary:

Environmental Monitoring Expert

We are seeking an experienced Environmental Monitoring Specialist to ensure compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Standard Operating Procedures (SOP), and regulatory requirements.

The ideal candidate will have sound knowledge of regulatory requirements and standards, including FDA, EU, ICH, ISO, and USP. They will be responsible for coordinating daily operations, reviewing results, performing monitoring tasks, and providing training and support to team members.

Key Responsibilities:

  • Schedule and coordinate daily operations of the QC Environmental Monitoring Group
  • Review results on appropriate documentation or in LIMS for all EM or any tests processed by the Third-party Laboratory
  • Perform and coordinate the monitoring of manufacturing environments and critical utility services across all GTA sites to ensure compliance with approved standards
  • Evaluate new materials for EM sample collection
  • Prepare trend reports as required, create STR projects, EM sampling protocols, Cleanliness reports, and EM studies
  • Provide front-line support in preparation for internal, customer, and regulatory audits

Requirements:

  • Bachelor of Science Degree/Community College Diploma (or equivalent) in a related discipline
  • Minimum five years of experience in Microbiology Laboratory/Environmental Monitoring in a Pharmaceutical environment
  • Strong knowledge of microbiological techniques, including aseptic technique
  • Excellent communication skills in English, with good technical writing skills
  • Strong organizational, interpersonal, and time management skills

Salary: $80,000 - $110,000 per year

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