Job Information
Boehringer Ingelheim QA Compliance Associate (Contract) in Burlington, CA, Canada
The Position
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 is a 2-year contract position and will support the Animal Health business unit.
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 guidance, 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 QA/QC 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.
Total Rewards
We offer a competitive salary, generous amount of paid time off (vacation, personal days, contingency paid time off days for Long Term Contract Employees), comprehensive and flexible benefits plan, Defined Contribution Pension Plan with company matching of RRSPs, Employee and Family Assistance Plan, employee and leadership development programs, and programs to support overall health and wellness for employees.
Visit https://www.boehringer-ingelheim.com/ca/careers/benefits-rewards
READY TO APPLY?
Click the "Apply Now" button below to submit your application.
We thank all applicants for their interest in our company. Please note that only candidates selected for an interview will be contacted.
Boehringer Ingelheim Canada is committed to providing accommodations for people with disabilities to support their participation in all aspects of the recruitment and selection process. If you require accommodation, we will work with you to meet your needs.
DEADLINE FOR APPLICATIONS
Applications for this position will be accepted until July 11, 2024.
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All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.