Quality Assurance Specialist

3 months ago

Mississauga, Canada AstraZeneca Full time

Provides technical and/or systems support in the marketing company quality function. Works independently and in cross-functional groups. The jobholder communicates frequently with various levels of management (including senior management) in different functions. Carries out complex technical project work.

Accountable for the effective management of Quality Systems and procedures required to facilitate GMP/GDP Compliance for drug product, medical devices and biologics in accordance with Health Canada regulations and guidelines, and AZ Quality Management System standards.

**Typical Accountabilities**:

- Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.
- Manager Accountabilities at AstraZeneca include Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness.
- Leaders with accountability for GXP areas are encouraged to understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improve its efficiency.

**Specific Responsibilities of Role Holder**:

- Provides technical/quality support to teams/projects on a day-to-day basis involving consultation on sophisticated quality issues to assess risk and impact on product safety, identity, strength, purity and quality.
- Acts as an advisor to facilitate sound resolution on a wide range of issues with a diverse group of employees from different business units and different AstraZeneca sites as the need arises.
- Provides timely and detailed assessments to peers and management. Proven ability to work independently and in project settings to deliver objectives.
- Keeps own knowledge of best practices, industry standards and new developments in quality management up to date.
- Leads trouble shooting activities to resolve existing problems, make complicated judgements and anticipate future developments in AstraZeneca’s Quality related needs.
- Responsible for managing Quality Standards and expectations across a broad range of services in order to provide a high quality, timely and efficient service.
- ** Employs prepared information to discuss, plan and help carry out improvement plans, priority setting, investigation reports, quality or performance improvement recommendations. An ability to seek out, collaborate with and engage customers and collaborators in the development of solutions is imperative.**:

- ** Responsible for the overall management and maintenance of assigned quality systems as outlined in current job curricula assignments.**:

- ** Ensures adherence to Quality, Health and Safety, Good Manufacturing Practice, Good Distribution Practice and regulatory requirements of own work and others work.**:

- ** Ensure that appropriate decisions are made, taking into consideration all relevant data, since inappropriate decisions could result in a product recall, adverse impact on patient health, non-compliance rating and impact on license to operate.**:
**Education, Qualifications, Skills and Experience**:

- Degree level or equivalent
- Diploma, certificate in a science related to the work being carried out combined with at least 5-7 years of practical experience.
- Experience of Good Manufacturing Practices and Quality environment
- Strong communication and influencing skills

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