Manager Labs/audit Quality Assurance, R&d Quality - Mississauga, Canada - AstraZeneca

AstraZeneca
AstraZeneca
Verified Company
Mississauga, Canada

1 month ago

Sophia Lee

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Sophia Lee

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Description

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.


Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.

Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.


Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work.

We know the health of people, the planet and our business are interconnected which is why we're taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.


As the independent second line assurance function for R&D, our mission in Quality Assurance is to achieve enduring excellence in auditing, quality management, quality risk assessment and enhance the R&D quality mindset for the benefit of our patients.


The job holder is responsible for:

  • Planning, leading, conducts and reports audit activities for R&D GxP risk-based audit programs
  • Support of GxP inspection activities
  • Management of CAPAs related to audit and/or inspection findings in collaboration with QA colleagues and functions owning the issues.
  • Support of QA activities such as CAPA tracking & followup
The Quality Assurance GxP accountabilities are split between the QA teams as below:

  • Audit team
  • GCP, GVP, GRP, LabGCP including strategy where applicable


  • LabsQA team

  • GLP, HBS, GLS, LabGCP, ISO 17025, CLIA including strategy

Audit

  • Plans, leads, conducts and reports audits in assigned GxP areas, such as investigator site and/or project audits
  • Supports lead auditors in the planning, conduct and reporting of more complex audits such as Process / System, External supplier
  • Works with contract personnel or consultants to prepare, conduct and report outsourced audits
  • Supports Supplier qualification activities (Operational Due diligence ODD) as assigned
  • Identify and summerise gaps during ODD

CAPA

  • Assesses need for, and assists in development of CAPA plans, approves and monitors plans to completion for assigned audits
  • Assists with the continuing followup of agreed audit CAPA actions from across QA to assist in the monitoring of QA Key Performance Indicators

Inspection

  • May support Quality Assurance colleagues to prepare for regulatory inspections and assist with planning and logístical arrangements

General Accountabilities

  • Ensures own tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelines
  • Promotes a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits
  • Communicates effectively with QA colleagues and business stakeholders
  • Maintains knowledge of relevant industry information affecting quality and compliance arena
  • May provide responsive and proactive quality and compliance advice to defined customers.
  • Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations
  • Travel expected

Education, Qualifications, Skills, and Experience

  • Degree level education or equivalent experience
  • Experience in pharmaceuticals or a related industry
  • Excellent analytical, written and oral communications skills
  • Fluent in written and spoken English
  • High ethical standards, trustworthy, operating with absolute discretion
  • Collaborative, influencing and interpersonal skills curious to understand business environment
  • Skilled at managing & using technology
  • Ability to develop professional networks with stakeholders

Desirable:


  • Audit Experience
  • Supplier qualification
  • Experience of regulatory health authority GxP Inspections

Great People want to Work with us Find out why:

  • GTAA Top Employer Award for 10 years
  • Top 100 Employers Award
  • Canada's Most Admired Corporate Culture
  • Learn more about working with us in Canada
  • View our YouTube channel

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