QA Compliance Specialist (Contract)
Top Benefits
About the role
Job Title:
QA Compliance Specialist (Contract)
Location:
Mississauga, ON
Date Posted:
6/12/2025
Job Number:
JO-2506-1949
Email this job
Bora Pharmaceuticals is a global leader in the development and manufacturing of branded, generic, and over the counter (OTC) healthcare and pharmaceutical products. Our mission is to ensure the mutual success of our partners by maintaining high standards of quality, reliability, and efficiency. At Bora, we believe that our own success is intertwined with that of our partners, driving us to consistently deliver exceptional results.
Our comprehensive pharmaceutical supply chain covers research and development, sales, and distribution. We focus on producing and marketing generic, brand, and OTC drugs to clients worldwide, with a dedication to meeting diverse healthcare needs.
Why join Bora?
- Competitive salary
- A modern and state-of-the-art facility
- An on-site cafeteria with dedicated chefs
- On-site gym and basketball court
POSITION DESCRIPTION
JOB TITLE: QA Compliance Specialist
DEPARTMENT: Quality Assurance
POSITION REPORTING TO: QA Manager
EMPLOYMENT TYPE: Contract (One 2-year contract and one 18-months contract)
NO OF POSITIONS: Two
THIS IS A FULL TIME CONTRACT POSITION: One 2-year contract and one 18-months contract
General Description:
QA Compliance Specialist to act as the QA support for commercial activities or new project transfers into Bora. Provide quality support for areas such as Analytical, Engineering, Production etc. to ensure GMP compliance and client regulatory requirements are maintained. Key responsibilities include but are not limited to the following:
Key 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 and other Quality related documents.
- Negotiate Quality Agreements with customers and suppliers.
- Confidently analyze processes and systems, identify vulnerabilities/gaps, establish remediation plan and lead implementation activities.
- Support 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.
- Conduct desktop assessments of suppliers and service providers to confirm GMP compliance status.
- Support multi-functional investigations using root cause analysis tools and develop CAPA plans or confirm effectiveness of CAPA plans.
- 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 regulatory declaration statements etc.
Educational Background:
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.
Job-Related Experience:
- 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.
Working Condition:
- Flexibility with Onsite Work Schedule and Occasional Extended Hours
Bora is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. Bora is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at accessibility@bora-corp.com. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.
About Bora Pharmaceuticals
Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in complex oral solid dose, liquids, semi-solids, ophthalmics and nasal sprays for pharmaceutical products. We operate from early phase clinical right through to commercial manufacturing with full packaging capabilities. From cell-line development and formulation to analytical services, clinical cGMP manufacturing and sterile fill/finish services, Bora now provides tailored development and manufacturing services to biologics developers. Bora owns and operates in ten state-of-the-art CGMP manufacturing facilities across Asia and North America – delivering to more than 100 markets around the world. Our sites have the highest international standards for manufacturing, packaging, R&D and analytical testing.
As a future focused CDMO, we know better than most that our own success is shaped by our partners victories. That's why, when you choose Bora - we make success more certain by following Bora’s 5Ps – Promises, Partnerships, Pride, People, and Progress. These 5 principles are Bora’s Pledge to our customers.
Follow us to find out more and keep up to date with Bora Pharmaceuticals.
QA Compliance Specialist (Contract)
Top Benefits
About the role
Job Title:
QA Compliance Specialist (Contract)
Location:
Mississauga, ON
Date Posted:
6/12/2025
Job Number:
JO-2506-1949
Email this job
Bora Pharmaceuticals is a global leader in the development and manufacturing of branded, generic, and over the counter (OTC) healthcare and pharmaceutical products. Our mission is to ensure the mutual success of our partners by maintaining high standards of quality, reliability, and efficiency. At Bora, we believe that our own success is intertwined with that of our partners, driving us to consistently deliver exceptional results.
Our comprehensive pharmaceutical supply chain covers research and development, sales, and distribution. We focus on producing and marketing generic, brand, and OTC drugs to clients worldwide, with a dedication to meeting diverse healthcare needs.
Why join Bora?
- Competitive salary
- A modern and state-of-the-art facility
- An on-site cafeteria with dedicated chefs
- On-site gym and basketball court
POSITION DESCRIPTION
JOB TITLE: QA Compliance Specialist
DEPARTMENT: Quality Assurance
POSITION REPORTING TO: QA Manager
EMPLOYMENT TYPE: Contract (One 2-year contract and one 18-months contract)
NO OF POSITIONS: Two
THIS IS A FULL TIME CONTRACT POSITION: One 2-year contract and one 18-months contract
General Description:
QA Compliance Specialist to act as the QA support for commercial activities or new project transfers into Bora. Provide quality support for areas such as Analytical, Engineering, Production etc. to ensure GMP compliance and client regulatory requirements are maintained. Key responsibilities include but are not limited to the following:
Key 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 and other Quality related documents.
- Negotiate Quality Agreements with customers and suppliers.
- Confidently analyze processes and systems, identify vulnerabilities/gaps, establish remediation plan and lead implementation activities.
- Support 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.
- Conduct desktop assessments of suppliers and service providers to confirm GMP compliance status.
- Support multi-functional investigations using root cause analysis tools and develop CAPA plans or confirm effectiveness of CAPA plans.
- 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 regulatory declaration statements etc.
Educational Background:
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.
Job-Related Experience:
- 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.
Working Condition:
- Flexibility with Onsite Work Schedule and Occasional Extended Hours
Bora is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. Bora is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at accessibility@bora-corp.com. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.
About Bora Pharmaceuticals
Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in complex oral solid dose, liquids, semi-solids, ophthalmics and nasal sprays for pharmaceutical products. We operate from early phase clinical right through to commercial manufacturing with full packaging capabilities. From cell-line development and formulation to analytical services, clinical cGMP manufacturing and sterile fill/finish services, Bora now provides tailored development and manufacturing services to biologics developers. Bora owns and operates in ten state-of-the-art CGMP manufacturing facilities across Asia and North America – delivering to more than 100 markets around the world. Our sites have the highest international standards for manufacturing, packaging, R&D and analytical testing.
As a future focused CDMO, we know better than most that our own success is shaped by our partners victories. That's why, when you choose Bora - we make success more certain by following Bora’s 5Ps – Promises, Partnerships, Pride, People, and Progress. These 5 principles are Bora’s Pledge to our customers.
Follow us to find out more and keep up to date with Bora Pharmaceuticals.