QA Specialist

**QA Specialist**

At AstraZeneca we believe in the potential of our people and we’ll develop you beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.

We are looking for a QA Specialist who is the responsible party for overseeing the design, implementation and delivery of a common Quality system and strategy for GMP and GDP activities across in Commercial marketing company for all of the AZ product portfolio in country. The QA Specialist participates in development of Global AZ Affiliate Quality Strategy and executes country strategy for Affiliate Quality and Marketing Company GMP/GDP aligned with AZ’s 2030 bold ambition strategy for market expansion, product launches and accessibility. The QA Specialist is accountable for assurance of compliance with worldwide standards for all local GMP & GDP activities and connects the affiliate offices the broader Operations Quality and R&D organisation operating under One AZ QMS.

**MAIN DUTIES AND RESPONSIBILITIES**

For the Italian Marketing Company the QA Specialist develops, supports and drives excellence in Affiliate GMP&GDP Quality activities to maintain the local License to Operate.

Primary point of GMP&GDP contact for the country and maintains an effective governance structure to ensure oversight of quality activities.
- Provides leadership for GMP & GDP (Good Manufacturing and Good Distribution Practice) strategy and activities across market and commercial SET area as the Quality partner to Commercial SET leader, Regional Commercial Head and Global Safety
- Participates in defining the strategy for the commercial global markets ownership and execution of Affiliate GMP and GDP Quality System and framework in country
- Define, develop, deploy and monitor the GMP/GDP policies and standards and execution in country markets
- Accountable for a Country Affiliate Quality Management Review process, preparation and execution and escalations to Operations, Commercial and R&D Sr. Leadership and SET members
- Represents Quality on cross-functional and cross SET teams and steering committees related to Affiliate market
- Drive global standardisation, simplification and improvement of Affiliate Quality business processes. Develops and sustains a high-quality organisation that delivers against global processes, and aims to continuously improve in competence, compliance standards and innovative delivery of results.
- Provide training, supporting and coaching structure for regional Quality Affiliate network roles
- Participates in strategy and regional objectives setting for the Affiliate Quality organisation
- Is the primary point of expertise for GMP & GDP activities impacting the affiliate organisation in country
- Plans, reviews and manages budget for the Country Affiliate Quality organisation
- Accountable for compliance assurance and working to one set of GMP & GDP standards and processes, as well as common GxP process across the Affiliate GxPs.
- Accountable for Country specific regulatory requirements related to manufacture and distribution of AZ product in country, including but not limited to release of product batched, resolution of Issue Management, recalls, audits and inspection readiness and compliance to gain and maintain AZ licence to operate.
- Responsible for Affiliate GMP&GDP input into divestments/acquisitions/licensing agreements in country
- Demonstrated 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 cost-effective service
- Employs prepared information to discuss, plan and help carry out improvement plans, priority setting, investigation reports, quality or performance improvement recommendations
- Ensures adherence to Quality, Health and Safety, Good Manufacturing Practice, Good Laboratory Practice and regulatory requirements of own work and others work
- Responsible for ensuring that policies and standards meet regulatory requirements
- Ensures compliance with Good Manufacturing Practice, Safety Health and Environment and all other relevant regulations
- Carries out compliance reviews and reporting for external suppliers including issue resolution with senior management and AZ site leaders, this may include, but is not limited to, the review and approval of investigation reports and participation in issue management teams
- Responsible for country preparation for Regulatory Agency and AstraZeneca inspections/audits and responses
- Supports local MC to deliver the license to operate, inc