R&D QA Operations Project Lead - Formulations & Launch

Apotex; Toronto; On-site; CAD 84,000 - 140,000; Full time

Benefits offered by this job

Bonus programs

Pension plan

Learning and development opportunities

Comprehensive benefits

Job summary

Apotex Inc. in Toronto is seeking a Project Leader, R&D QA Operations to oversee quality for Formulations Development and New Product Launch processes at Signet and Etobicoke sites.

You will review master documentation and batch records, lead investigations, close deviations, support regulatory inspections, and mentor junior staff to ensure compliant product releases and effective CAPA and change controls.

Qualifications

• B.Sc. in Chemistry or Biochemistry or related science.
• Knowledge of GMP/cGMP requirements.
• Experience with solid dose manufacturing techniques.
• Proficiency in technical report writing and English communication.

Responsibilities

• Act as primary R&D QA contact for non-commercial batches at Signet/Etobicoke.
• Review master docs, protocols, reports, and associated change controls.
• Lead investigations with SMEs and trend quality issues.
• Ensure batch records are complete and deviations closed prior to release.
• Support regulatory inspections and QA for IMPs, registrations, and demo batches.
• Coordinate deviation investigations and CAPA activities; lead product launches.

Skills

GMP knowledge

Solid dose manufacturing

Independent & team work

Time management

Technical report writing

English communication

Education

B.Sc. in Chemistry or Biochemistry

Tools

MS Office

Laboratory LIMS

Job description

Apotex Inc. in Toronto is seeking a Project Leader, R&D QA Operations to oversee quality for Formulations Development and New Product Launch processes at Signet and Etobicoke sites.

You will review master documentation and batch records, lead investigations, close deviations, support regulatory inspections, and mentor junior staff to ensure compliant product releases and effective CAPA and change controls.