QA Compliance Specialist

Bora Pharmaceuticals•Mississauga, ON

1d•CA$68,000 - CA$85,000•Onsite

About The Position

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. Their key responsibilities are listed but not limited to the following.

Requirements

Minimum Level of Education: Bachelor of Science degree or College Diploma in a science related field.
Computer proficiency and proficiency in Microsoft Office applications and the ability to quickly adapt to working with new electronic systems.
Minimum 5 years experience in a similar Quality related role within the pharmaceutical or related industry.
In-depth knowledge and understanding of global GMP requirements.
Demonstrated understanding of the regulatory framework and current industry standards.
Knowledge of pharmacopeia requirements and processes.
Understanding of risk management principles.

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.