PurposeThe Reviewer (Analytical Chemist) is a key member of the R&D team who will be responsible to review all GMP data generated as a part of testing & other activities carried out in a timely manner as per organization needs. This role would also require preparation of documents as needed. The role would require involvement in the day-to-day activities of the assigned projects & provide support to senior reviewer(s).Position / Job TitleAnalytical Chemist (Reviewer)DepartmentAD - R&DReporting ToManager - Research & DevelopmentLocationConcord - CanadaYears of Experience3 - 6 yearsDosage FormNasal / LiquidJob Responsibilities / Deliverables\xc2\xb7 Review all GMP analytical data generated as a part of testing\xc2\xb7 Review of study reports as per requirement\xc2\xb7 This role would be for an individual contributor\xc2\xb7 The person is required to work hand in hand with the development & GMP teams of the organization & support other senior Reviewer(s).\xc2\xb7 The lab activities/ work allocation/ work priorities will be managed by managers & team leads\xc2\xb7 Audit laboratory documentation for compliance with quality & regulatory guidances\xc2\xb7 Conduct laboratory investigations and write deviations and LIRs\xc2\xb7 Participate in method development, method validation, method transfer, stability, characterization, and in-vitro bioequivalence activities for new pharmaceutical products as per requirements\xc2\xb7 Participate in HPLC and GC testing (including troubleshooting and problem solving) and other required testing on a need basis\xc2\xb7 Evaluate all results generated for consistency and accuracyQualifications & Pre-Requisites\xc2\xb7 Graduate / Post graduate in chemistry, biochemistry, pharmaceutical sciences or other relevant scientific discipline, or equivalent combination of education and industry experience\xc2\xb7 3 - 6 years in a relevant industrial environment \xc2\xb7 Prior experience in a QA/reviewer role: generic or specialty pharmaceutical company; pharmaceutical contract service organization; analytical or formulation laboratory with ANDA directed projects would be as asset\xc2\xb7 Ability of collaborate & work with the current analytical team members\xc2\xb7 Possess basic method development / QC review experience to critically review the data generatedAdditional notesThe individual may be required to work in the afternoon shift on a need basisJob Type: Full-timePay: $48,000.00-$50,000.00 per yearBenefits:
Dental care
Extended health care
On-site parking
Schedule:
8 hour shift
Evening shift
Monday to Friday
Ability to commute/relocate:
Concord, ON L4K 4J1: reliably commute or plan to relocate before starting work (preferred)
Education:
Bachelor's Degree (preferred)
Experience:
Analytical chemist Reviewer: 1 year (required)
Work Location: In person
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