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QA Compliance Specialist (Contract) - Job Opportunity at Bora Pharmaceutical Services

Mississauga, Canada
Contract
Senior
Posted: April 6, 2025
On-site
CAD 85,000 - 105,000 annually based on the senior level position in the Greater Toronto Area pharmaceutical sector

Benefits

Modern state-of-the-art facility with advanced pharmaceutical manufacturing capabilities
On-site wellness facilities including professional gym and basketball court
Professional culinary services with dedicated on-site cafeteria
Professional development through exposure to global pharmaceutical operations

Key Responsibilities

Lead strategic compliance management for global market products with focus on regulatory alignment
Drive quality assurance in product transfers and new initiatives across multiple operational areas
Develop and maintain critical quality documentation including SOPs, specifications, and risk assessments
Execute supplier quality management program including compliance assessments and remediation planning
Lead cross-functional investigations and CAPA implementation with business impact focus
Provide strategic quality training and development for organizational capability building

Requirements

Education

Bachelor of Science degree or College Diploma in a science related field

Experience

Minimum 5 years experience in a similar Quality related role within the pharmaceutical or related industry

Required Skills

In-depth knowledge of global GMP requirements Understanding of regulatory framework and industry standards Knowledge of pharmacopeia requirements and processes Risk management principles expertise Computer proficiency and Microsoft Office applications Ability to adapt to new electronic systems
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical manufacturing sector is experiencing increased regulatory scrutiny, particularly in contract manufacturing organizations (CMOs), driving higher demand for experienced QA professionals. Digital transformation in pharmaceutical quality systems is creating need for specialists who can bridge traditional GMP knowledge with modern electronic quality management systems. Global supply chain complexities post-pandemic have elevated the importance of supplier quality management expertise.

Role Significance

Typically part of a 5-10 person quality assurance team in a medium to large pharmaceutical manufacturing facility
Senior individual contributor role with significant influence on quality systems and compliance strategies

Key Projects

Implementation of new quality management systems for product transfers Supplier quality program development and optimization Regulatory inspection preparation and management Quality system harmonization across global requirements

Success Factors

Deep understanding of global pharmaceutical regulations and ability to interpret requirements for practical implementation Strong project management skills with ability to handle multiple concurrent quality initiatives Excellent stakeholder management capabilities across internal teams and external partners Strategic thinking in risk assessment and mitigation planning

Market Demand

High demand with growing emphasis on contract manufacturing organizations and increasing regulatory requirements in pharmaceutical manufacturing

Important Skills

Critical Skills

GMP and regulatory knowledge - Essential for ensuring compliance and driving quality improvements Investigation and CAPA management - Critical for maintaining product quality and regulatory compliance Risk assessment capabilities - Fundamental to modern pharmaceutical quality systems

Beneficial Skills

Project management methodologies Statistical analysis skills Quality management system software expertise Change management capabilities

Unique Aspects

Contract role offering exposure to multiple product types and global markets
Opportunity to work in modern pharmaceutical manufacturing facility
Combination of technical quality responsibilities with strategic supplier management

Career Growth

2-4 years in current role before advancement, depending on project success and organizational growth

Potential Next Roles

Quality Assurance Manager Quality Systems Director Regulatory Affairs Manager Compliance Director

Company Overview

Bora Pharmaceutical Services

Bora Pharmaceuticals is a growing contract development and manufacturing organization (CDMO) with significant presence in North America and Asia

Mid-sized CDMO with strong position in generic and OTC product manufacturing, competing with established global players
Strategic location in Greater Toronto Area pharmaceutical hub with access to skilled talent pool
Professional pharmaceutical manufacturing environment with emphasis on quality and compliance, balanced with employee wellness initiatives
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