Compliance Officer - Financial Services - Regulatory (Mississauga)

Compliance Officer - Financial Services - Regulatory (Mississauga)

06 Sep
|
Bora Pharmaceuticals Services
|
Mississauga

06 Sep

Bora Pharmaceuticals Services

Mississauga

About Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide.

At Bora

Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain. This is a fulltime fixed term contract (FTC) and a replacement position for 18 months. QA Compliance Specialist to act as the QA support for new project transfers into Bora. Provide quality support for areas, such as Analytical, Engineering, Process Leads and Production to ensuring GMP compliance and client regulatory requirements are maintained.

Key Technical Responsibilities: Plan and proactively manage compliance requirements for a complex mix of products for global markets.

Provide

Quality support for various projects and initiatives including product transfers. Issue or approve Master Data, Standard Operating procedures, Master forms, Technical Reports, Risk Assessments, Specifications, Test Methods, Quality Agreements and other Quality related documents. Confidently analyze processes and systems, identify vulnerabilities/gaps, establish remediation plan and lead implementation activities.

Manage various aspects of the supplier management program including the assessment of supplier information to ensure regulatory compliance, responding to quality alerts and performing process reviews to ensure on-going compliance through the review of documents and data.



Lead or support investigations using root cause analysis tools with multi-functional groups and develop CAPA plans or confirm effectiveness of CAPA plans. Provide support for various aspects of Drug Establishment Licence Management and Importation Program including annual reviews, data management and quality agreements.

Actively participate in inspections and internal audits in various roles as required. Lead or contribute to cGMP training of staff. Support other team activities including but not limited to entering data in various electronic systems, generating monthly quality metrics, drafting declaration statements etc.

Bachelor of Science degree or College Diploma in a science related field. Area(s) of Specialization: Computer proficiency and proficiency in Microsoft Office applications and the ability to quickly adapt to working with new electronic systems.

Experience and Technical Skills Minimum 5 years experience in a similar Quality related role within the pharmaceutical or related industry. Demonstrated understanding of the regulatory framework and current industry standards. Understanding of risk management principles.

Updates regarding application status may be communicated via email or through the online applicant profile, where applicable. These tools do not make final hiring decisions. Market-competitive salary and performance-based incentives Comprehensive health coverage including medical, dental, and vision insurance Retirement savings plans with employer contributions Paid time off and flexible work arrangements Employee Assistance Program and Mental Health Resources We’re proud to be an equal opportunity employer, committed to building a diverse and inclusive workplace where everyone feels empowered to contribute and grow.

If you require accommodation during any stage of the application or interview process, or if you’d like to learn more about our accessibility policies, please contact us at [email protected]. Bora Pharmaceuticals is focused on developing and manufacturing branded, generic and over the counter (OTC) healthcare and pharmaceutical products for patients around the globe.

At Bora

Pharmaceuticals, we see it as our mission and our duty to make our mutual success more certain.

📌 Compliance Officer - Financial Services - Regulatory (Mississauga)
🏢 Bora Pharmaceuticals Services
📍 Mississauga

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