QA Compliance Specialist

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. This job posting reflects a current vacancy within the organization. The position is active, approved, and intended to be filled as part of our staffing needs. This posting is for an existing and currently open 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. 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.

Minimum Level of

Education:

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.

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.

Flexibility with Onsite Work Schedule and Occasional Extended Hours.

In accordance with Ontario’s pay transparency requirements, candidates will be notified when they are no longer under consideration or once the vacancy is closed. Updates regarding application status may be communicated via email or through the online applicant profile, where applicable. As part of our recruitment process, we may use technology-assisted tools, including automated systems, to support the review and assessment of applications.

These tools do not make final hiring decisions.…