QA Compliance Associate

1 week ago


Mississauga, Ontario, Canada Bora Pharmaceutical Services Full time

Location:

  • Mississauga, ON
    Date Posted:
  • 4/26/2024
    Job Number:
  • JO 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, futurefocused 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 longlasting 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 overthecounter (OTC) drugs to clients around the world.
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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%
  • Onsite gym and basketball court
  • Tuition reimbursement programs
    TITLE: QA Compliance Associate
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DEPARTMENT:Quality Assurance

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POSITION REPORTING TO: QA Compliance Supervisor

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LOCATION:5 days on site

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TERM:Full-Time, Permanent

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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.
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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 offsite 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 onthejob 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.

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