Quality Assurance Lead - APICOM

Quality Assurance Lead

Location: Dublin, Ireland

Closing date: 16th March 2025

Competitive Salary and Bonus

Introduction to role

As a QA Lead, you will provide QA expertise for the quality assurance oversight of manufacturing, testing, release, warehouse and distribution, quality management systems, and other related activities for Active Pharmaceutical Ingredients at the API Facility at College Park, Dublin. You will ensure that the manufacturing, testing, and operation of support systems meet all regulatory requirements, AstraZeneca standards, and the appropriate level of compliance. This service must be delivered efficiently while maintaining a reliable and robust output. You will participate in quality initiatives and improvement projects to deliver enhanced compliance at a reduced cost. The role holder impacts directly on the value stream by influencing decisions through advice to others. They are responsible for the professional management of all the associated quality management systems within the API Facility at College Park, Dublin.

Accountabilities

• Provide QA expert advice on GMP/GxP/regulatory requirements to the facility.
• Maintain the Quality Assurance framework for the site in compliance with regulatory requirements, AstraZeneca standards, and the appropriate level of compliance.
• Advise on deviations and contribute to the resolution of deviations.
• Ensure compliance with the change management processes within the facility.
• Provide oversight of the site documentation management system including review and approval of GMP SOP’s.
• Perform product release activities.
• Ensure plant readiness for internal and external audits and inspections.
• Identify risks and opportunities using appropriate risk management techniques balanced with compliance with quality principles and regulatory requirements.
• Contribute to the Product Quality Review processes.
• Ensure all Equipment and Computer Systems are validated to the required GMP standards and are maintained in a validated state.
• Complete GMP training within the API facility.
• Proactively look for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whilst ensuring an appropriate level of compliance.
• Collaborate with cross-functional teams, including Manufacturing, Supply Chain, Manufacturing Science, Process Technology, Engineering and Maintenance, Quality Control, to resolve all quality related matters.
• Maintain ongoing personal professional development.
• Contribute to the continuous improvement of Quality and operational processes through participation in team meetings, training sessions, and quality initiatives.

Essential Skills/Experience

• B.A. / B.Sc. or equivalent in Biological Sciences, Chemistry or other science or equivalent experience in regulated industry. A comprehensive understanding of own quality assurance function, as well as a strong understanding of other functions and how they contribute to achieving the objectives of the business within a lean manufacturing environment.
• Minimum 3-5 years Quality Assurance experience in a GMP regulated pharmaceutical facility.
• Competent to professional knowledge of current GMP requirements and regulatory processes. Experience working with regulatory / SOP / GxP requirements and driving compliance.
• Ability to make complicated judgements, within general operating guidelines
• Strong attention to detail.
• Good communication and influencing skills including cultural awareness.
• Understands own leadership styles, capabilities & their impact on the team
• Broad understanding of Supply Chain activities and processes.

Desirable Skills/Experience

• Excellent organizational and time management skills, with the ability to prioritize tasks and meet deadlines.
• Effective communication and teamwork skills, with the ability to collaborate across departments and levels of the organization.
• Experience in preparation, hosting and response to regulatory inspections.
• Experience in leading change programs across Quality.
• Change Management, Change Agent roles.
• Program and project management experience.
• External network and industry current practice knowledge.
• Competent financial governance (fiscal awareness).

At AstraZeneca, you will work on diversified tasks with a global team. You will engage in multiple projects while partnering with knowledgeable colleagues across various business functions. Be exposed to new ways of thinking that help us grow collectively and as individuals. This is a place where you will feel included in the conversation; every voice is heard and matters.

Join us at AstraZeneca and make a real difference! Apply now!

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.