Reviewer - BioPharma Product Testing Inc. Job Toronto area,Ontario Canada,Quality Assurance

Position: Reviewer - Eurofins BioPharma Product Testing Inc.

Job Description

Eurofins Bio Pharma Product Testing Toronto, Inc. is seeking a detail-oriented and analytical Reviewer to join our team in Toronto, Canada. In this critical role, you will be responsible for ensuring compliance with applicable regulations and maintaining the highest quality standards in our biopharmaceutical testing processes.

Review of all analytical data/documents related with R&D and QC testing, e.g.: method validation, method verification, method transfer, finished products, bulk, raw material and stability study products as per GMP requirements.

Prepare and review protocol, report and test method for method validation, method verification, method transfer study.

Review all raw data and chromatograms using different software (e.g. Empower, Chromeleon, Mass Hunter, Analyst software etc.) and then release report/COA on e-LIMS.

Train junior analysts in method validation, method verification and method transfer study including related software usage (Empower, ETQ, Chromeleon, other software associated with LC-MS/MS. GC-MS/MS, ICP-MS/OES).

To ensure data integrity is maintained in all the process.

Participate in and/or lead out of specifications investigations OOS.

Initiate CCR and complete Corrective and Preventive Actions (CAPA’s).

Participate in Internal, Customer and Regulatory Audits.

Assist laboratory personnel with documentation issues and provides coaching and guidance to R&D team.

Perform analysis using different instruments (e.g. HPLC, GC, LCMSMS, GCMSMS, UV-Vis, FTIR) and wet Chemistry techniques.

Provide technical support to clients in relation to R&D, Validation and Technology Transfer.

Troubleshoot technical issues/ difficulties with methods.

Archive all GMP documents related with raw data, test method, protocol & report.

May be essential to perform work in weekend, after hours and rotating shift work (as required).

Follows up with analysts/technicians to ensure that all necessary corrections are corrected in accordance with Good Manufacturing Practices standards.

Audits calibration related documents and other R&D /QC documents;

All other jobs assigned by Department Head of R&D.

Review and determine the status of quality documents, including raw laboratory data, validation studies, logbooks, and calibration reports

Provide support in maintaining the Quality System, including drafting and updating quality procedures

Assist with internal and external audits to ensure compliance with GMP and ISO 17025 standards

Review and verify the accuracy of reports and accompanying raw data according to study protocols, methods, and relevant SOPs

Interact with department staff to gather information for report writing and auditing purposes

Log and review complaints, compiling required ISO 17025 and GMP documents for evaluation

Manage the internal auditing program and ongoing tracking of GMP and ISO 17025 documents

Support the training of new staff and review training records

Assist in maintaining ISO 17025 and GMP accreditation

Collaborate with cross-functional teams to ensure consistent quality standards across the organization

Qualifications

Bachelor's degree or diploma in a science-related discipline

Over 3 years of experience working in a pharmaceutical regulated Laboratory environment or Pharmaceutical Company.

Ability to work with electronic systems and other lab equipment to be able to perform audit trail of testing records.

Knowledge of GC, HPLC, UV, IR, LC-MS/MS. GC-MS/MS, ICP-MS/OES and other analytical instrument.

Sound knowledge of Health Canada and FDA regulations.

Comprehensive knowledge of ISO 17025 and GMP requirements

GMP experience in the biopharmaceutical industry preferred

Strong understanding of quality assurance processes and regulatory compliance in the pharmaceutical industry

Excellent written and verbal communication skills

Exceptional organizational abilities with a high level of accuracy and attention to detail

Proficiency in MS Office suite, particularly Excel, Word, and Outlook

Experience in quality document review and auditing

Familiarity with corrective and preventive action (CAPA) processes

Ability to multitask and remain calm under pressure

Strong analytical skills with the ability to…


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