Quality Assurance Ops Lead – Pharma Manufacturing

Bora Pharmaceuticals; Mississauga; Hybrid; CAD 68,000 - 85,000; Full time

Benefits offered by this job

Health coverage

Retirement plan

Paid time off

Professional development

Wellness programs

Job summary

Bora Pharmaceuticals in Mississauga, ON, is seeking an Operational Quality Specialist to support quality assurance activities across QA systems, equipment qualification, deviations, and batch record release.

The role requires 2+ years in pharma, a science/engineering degree, and strong writing and communication skills. Hybrid work with three onsite days per week is offered, with competitive compensation and benefits.

Qualifications

• Experience in Operational Quality Assurance or related role with similar responsibilities; Minimum 2 years in Pharma industry.
• Adequate knowledge of regulatory framework and demonstrated ability to make informed decisions.
• Demonstrated ability to participate in projects or change initiatives with the ability to make sound quality decisions.
• Experience with statistical software, SAP.

Responsibilities

• Prepare and implement quality assurance procedures (such as SOPs) and review as required.
• Investigate complaints, deviations, and product incidents ensuring thorough investigations and CAPAs.
• Review IQ/OQ/PQ documentation and prepare/review reports.
• Review batch records and release/reject batches per procedures.
• Participate in quality system improvement projects and new product introductions.
• Coordinate planned changes and ensure compliance with quality procedures.
• Coordinate responses to audit observations and internal improvement documents.
• Be accountable for team and site metrics.
• Participate in inspections as host, auditor, and auditee.

Skills

Interpersonal skills

Communication skills

Technical report writing

Education

Bachelor's degree in science/engineering/related field

Tools

SAP

Job description

Bora Pharmaceuticals in Mississauga, ON, is seeking an Operational Quality Specialist to support quality assurance activities across QA systems, equipment qualification, deviations, and batch record release.

The role requires 2+ years in pharma, a science/engineering degree, and strong writing and communication skills. Hybrid work with three onsite days per week is offered, with competitive compensation and benefits.