QA Compliance Associate (17 Months Job Rotation)

The Position 

Ready to make an impact? Boehringer Ingelheim is looking for a dynamic, detail-driven Quality Compliance Associate (QCA) supporting Animal Health business to join our Commercial Quality Assurance team who’s passionate about quality and excited to help deliver high-quality products to Canadian patients and customers. 

The Quality Compliance Associate (QCA) role is part of the Quality Management System (QMS) in Boehringer Ingelheim Quality and has 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 will actively contribute and support the establishment, maintenance,compliance and continuous improvement of the BOPU Canada QMS with all relevant health authority, corporate, Good Manufacturing Practice (GMP) and Good Distribution and Storage Practices (GDSP) requirements.

The QCA contributions in the implementation, maintenance and continuous improvement of the QMS, processes related to the commercial product supply at BOPU Canada is a key success factor for delivering consistent quality product to Canadian customers.

This job posting is for an existing vacant position. 

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 dispositon 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’s degree in Pharmaceutical Sciences, Chemistry, or related scientific field.
•    Demonstrated knowledge and hands on experience with GMP, Quality Control, and GDSP in the pharmaceutical industry.
•    Excellent attention to detail, organizational skills, and analytical thinking.
•    Strong written and verbal communication skills.
•    Ability to collaborate cross-functionally and work independently.
•    Sound judgment when balancing compliance and business needs.
•    Proficiency in Microsoft Office, SharePoint, Adobe Acrobat. 
•    Experience in TrackWise and SAP (an asset).
•    Special projects as assigned. 
•    Ability to travel occasionally for business needs.

*Canadian Importer and Distribution Drug experience is preferred

Total Rewards