Pharmaceutical Data Reviewer/Réviseur de données pharmaceutique

Job summary

Review, verify, and approve laboratory analytical data and records for accuracy, completeness, traceability, and compliance with approved methods, SOPs, and regulatory requirements. Investigate anomalies and OOS/OOT results, support audits and quality improvements, maintain compliant records, and train analysts in data integrity and documentation practices.

Job details

Role Description The Pharmaceutical Laboratory Data Reviewer/Réviseur de données laboratoire pharmaceutique is a full-time, on-site role based at Pathogenia Lab in Dorval, QC. This role is responsible for reviewing, verifying, and approving analytical data generated in the laboratory to ensure accuracy, completeness, and compliance with internal SOPs and regulatory standards. The person is expected to work in the afternoon shift starting at 2:00 pm. Responsibilities Review complete analytical packages: spreadsheets, chromatograms, spectra, laboratory notebooks, raw data, and final reports. Verify the accuracy of calculations, transcriptions, and units. Confirm compliance with approved methods, SOPs, specifications, and protocols. Verify sample traceability and consistency with historical results (trends, OOT/OOS). Compliance and Data Integrity Ensure adherence to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate). Verify system access, audit trails, and data backups. Identify anomalies, incidents, deviations, or OOS/OOT results and initiate investigations in accordance with procedures. Participate in and/or lead Out of specifications Investigations OOS including Client communication Approve or reject analytical results within the quality system. Draft or contribute to incident reports, CAPAs, and root cause analyses. Ensure compliant archiving of analytical records. Quality Support and Continuous Improvement Participate in internal audits, external audits, and regulatory inspections. Contribute to updating SOPs, forms, and work instructions. Train and mentor analysts on good documentation practices and data integrity. Participate in periodic reviews of trends and quality indicators. Qualifications Strong analytical and data review skills, with the ability to evaluate raw laboratory data, calculations, and reports for accuracy and consistency. Bachelor of Science degree (or equivalent combination of education and experience such as College with 5-10 years of pharmaceutical QC testing/records review experience) in Chemistry, Biochemistry or related biological science or equivalent in job experience. Over 2 years of experience working in a pharmaceutical regulated Laboratory environment or Pharmaceutical Company. Ability to work with electronic systems (eg. LIMS) and other lab equipment to be able to perform audit trail of testing records. Knowledge of GC, HPLC, UV, IR, ICP-MS/OES and other analytical instrument. Sound knowledge of Health Canada and FDA regulations. Quality Assurance /Quality control audit background in pharmaceutical industry is an asset Extended hours or weekend work may be required from time to time.

What you’ll do

Review, verify, and approve laboratory analytical data and records for accuracy, completeness, traceability, and compliance with approved methods, SOPs, and regulatory requirements. Investigate anomalies and OOS/OOT results, support audits and quality improvements, maintain compliant records, and train analysts in data integrity and documentation practices.

Requirements

Requires a bachelor’s degree in chemistry, biochemistry, or a related biological science, or equivalent education and experience; a college education with 5–10 years of relevant pharmaceutical QC testing or records review experience is also cited. Candidates need more than two years in a regulated pharmaceutical laboratory or company, knowledge of analytical instruments and Health Canada and FDA regulations, and the ability to review electronic records and audit trails.

Listed skills

• Regulatory Compliance · Preferred
• Root Cause Analysis · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Analytical Data Review
• Pharmaceutical Quality Control
• Data Integrity
• ALCOA+ Principles
• Good Documentation Practices
• HPLC
• GC
• UV Spectroscopy
• IR Spectroscopy
• ICP-MS/OES
• LIMS
• Audit Trail Review
• OOS/OOT Investigations
• Root Cause Analysis
• CAPA
• Regulatory Compliance

Job areas

• Science & Research
• Healthcare
• Data & Analytics
• Administrative