QA Compliance Associate

6 months ago

Burlington, Canada BI Canada Ltd Full time

**The Position**:
This is a 2-year contract position and will support the Animal Health business unit.

The Quality Compliance Associate (QCA) is an important role in supporting and maintaining the quality and compliance at Business Operating Unit (BOPU) Canada by ensuring all internal and external health authority and corporate requirements are implemented, monitored, adhered to and improved when required.

The QCA role will primarily be focused on batch dispositions, change controls, deviations, CAPAs, product complaints, inspections/audits, QA documentation reviews and sample testing.
Detailed knowledge of Canadian GMP, with minimum 2-year working experience in QA/QC role in the pharmaceutical industry. Working experience in the animal health environment is an asset.

**Responsibilities**:
**AUDITING/ INSPECTIONS**:

- Actively participate and support health authority inspections, internal audits, self-inspections, and external service providers/suppliers audits including CAPA response plans/CAPAs resulting from audit findings under the direction of the HoCQA and/or SQCA.
- Support quality issues with potential for market actions and market recall activities as required.
- Contribute to review of QAAs.
- Actively contribute to continuous quality and compliance optimization opportunities within BOPU Canada.
- Promptly escalate quality issues to senior QA team.

**TECHNICAL PRODUCT COMPLAINTS**:

- Initiate TPCs in Trackwise including follow-up with complainant when required to obtain additional information.
- Enter complaint sample information in Trackwise and coordinate shipment of complaint samples to investigating site when required.
- Act as a back-up to senior QA team to close out TPCs in Trackwise when required.

**BATCH DISPOSITIONS**:

- Ensure batch dispositions are made in compliance with regulatory marketing authorization, health authority and corporate requirements for marketed products in Canada.
- As part of the batch disposition process, manage the associated activities of creating, maintaining, filing, reviewing and assessing technical documents (batch documentation, master documents, change controls, deviations, investigations, CAPAs, unique identifier, retains and sample testing) including coordinating communications and QA activities with 3PL.
- Ensure timely review, approval and release of products for distribution as per health authority regulatory requirements.
- SAP user for QM transactions
- Support product launch activities including local repackaging activities.
- Manage reference standards for sample testing.
- Support SQCA in analytical method transfers with contract laboratories.

**COMPLIANCE ACTIVITIES**:

- Plan and manage for timely review of annual confirmatory testing, associated test results/ data and executed batch record reviews for product portfolio.
- Assist senior QA team in preparation and review of product quality and stability reviews when required.
- Assist senior QA team in preparation and review of trending reports for TPCs, events and deviations.
- Escalate quality issues to senior QA team promptly.

**QUALITY OPERATIONAL ACTIVITIES**:

- Support senior QA team in performing periodic SOP reviews including reviewing/commenting on new or existing local procedures and initiating new SOP development when required.
- Participate in reviewing draft /updated health authority and global guidances, regulations and procedures.
- Manage controlled documents using eDMS.

This position is based in the Burlington, Ontario office located at 5180 South Service Road and is **flexible.**
Employees in flexible roles are required to be at the office a minimum of 50% of the time each month and must report to the office when requested and required by their Manager/Department.

**Requirements**:

- Bachelor of Science in pharmaceutical or chemistry, or closely related discipline.
- Detailed knowledge of GMP, quality and compliance regulations with practical experience and expertise in QC/QA in the pharmaceutical industry
- Demonstrate a commitment to quality in all work and continuous improvement activities
- Attention to detail including strong organizational, time-management, analytical, problem-solving and planning skills
- Excellent written and verbal communication skills
- Demonstrate strong, proactive communication and negotiation skills to facilitate results and to develop and maintain collaborative working relationships with internal and external stakeholders
- Ability to work independently and effectively with team members and other stakeholders
- Sound judgment when balancing compliance and business needs to ensure that issues are identified, clearly articulated, escalated and resolved with the appropriate level of sensitivity to timing, risk consideration and overall business impact.
- Special projects as assigned.
- Highly proficient in using Microsoft Office Teams, Word, Excel, PowerPoint, Sharepoint and Adobe Acrobat.
- Ability to travel for business, as needed.

**T

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