QA Compliance Associate

Mississauga, ON

4/26/2024

JO-2404-1704

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. As an ambitious, future-focused company, we know better than most that our own success is shaped by our partners victories. At Bora, we insist on high quality, reliability, and efficiency without any compromises. Dedication to these high standards is how we create a long-lasting company culture that is the bedrock for our growth.

We cover the entire pharmaceutical supply chain from research and development to sales and distribution. We focus on manufacturing and selling generic, brand, and over-the-counter (OTC) drugs to clients around the world.

Why join Bora?

• Competitive salary and generous annual bonus
• 3 weeks vacations + paid personal and sick days
• Extended Health Care and Dental Benefits Programs
• Defined Contribution Pension Plans (DCPP) matched up to 4%
• On-site gym and basketball court
• Tuition reimbursement programs

Click here for a video tour of our Mississauga facility: https://lnkd.in/evhPktDN

POSITION DESCRIPTION

TITLE: QA Compliance Associate
DEPARTMENT:Quality Assurance
POSITION REPORTING TO: QA Compliance Supervisor
LOCATION:5 days on site
TERM:Full-Time, Permanent

General Description
QA Compliance Associates ensure Bora’s processes meet established quality standards. They provide quality support for cGMP compliance requirements relating to document management to ensure inspection readiness of the site at all time. Their key responsibilities are listed but not limited to the following.

Responsibilities

• Proactively manage compliance requirements for a complex mix of products for global markets.
• Administer paper and electronic GMP documents such as Batch Records, logbooks, specifications, methods, SOPs, Master Forms, Technical and Regulatory Documents etc. This includes document attributes data verification, and document scanning, filing, and uploading into electronic system (e.g., CDMS or ZenQMS).
• Act as administrators for the document management system ZenQMS and other systems within area of responsibility. This requires development of superuser knowledge of the relevant systems.
• Maintain accurate inventory of document location within the Document Management Center and ensure working and document storage areas are kept organized and clutter free.
• Work with Learning and Development to ensure documents uploaded to electronic system (e.g., ZenQMS) are aligned with Learning Management System.
• Prepare and archive documents as required to off-site storage. Coordinate temporary retrieval and destruction of documents, ensuring required documented approvals are obtained.
• Author/revise documents such as SOPs and MFs pertaining to area of responsibility.
• Prioritize and fulfil requests for documents and data, and support and maintain relevant databases.
• Support the movement of paper documents to electronic format as required.
• Collect metrics and support process improvement activities.
• Support investigations and CAPA development.

Qualifications
Experience and Skills

• Less than 1 year experience in a similar role in the pharmaceutical or related industry

Education
Required:

• High School or on-the-job experience through years of service in the Pharma or related industry

Preferred:

• College Diploma
• Good knowledge of GMP regulations, SAP Navigation, ability to make informed decisions for problem solving.
• Excellent interpersonal and communication skills.
• Thorough attention to detail is key for this role.
• Good computer skills and data management skills.

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 ataccessibility@bora-corp.com. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.