QC System Senior Specialist - APICOM

QC System Senior Specialist

Location: Dublin, Ireland

Closing date: 4th February 2025

Competitive Salary and Bonus

Introduction to role:

Join us as a Quality Control Systems Specialist, where you will be responsible for maintaining master data for Quality within various systems such as SAP, GQCLIMS, eLab, 1Lab, Empower, EM, MODA, WebCoA, CIMS, and eWM. You will coordinate key documentation approvals efficiently within QC to ensure compliance with Quality Standards. Additionally, you will provide first-line support for these systems and collaborate with others to manage technical evaluations and analytical procedures for products and systems. Your role will also involve supporting cross-functional multi-skilled teams.

Accountabilities:

• Provide project support to cross-functional multi-skilled teams.
• Support the development of technical improvement plans for processes or systems.
• Collaborate with others to define initiatives to improve quality performance that will deliver business benefits.
• Manage certain aspects of improvement projects, potentially including resource requirements, timing, and benefits tracking.
• Support and lead aspects of the technical evaluation of systems, processes, or analytical procedures.
• Maintain Master Data/specifications in SAP and GQCLIMS.
• Provide data from QC/IT systems.
• Provide standard and non-standard CoAs.
• Offer first-line support and end-user training for each of the QC systems.
• Provide QC support for internal and external audits.
• Support with Change controls and deviations for the QC laboratory.
• Assist with Analytical Tech Transfer protocols and equipment plans.

Essential Skills/Experience:

• Experience of working in a GMP environment.
• A comprehensive understanding of how the quality assurance function operates, as well as an understanding of other functions and how they contribute to achieving the objectives of the business within a lean manufacturing environment.
• Good knowledge of IT systems used by QC and how to maintain/update data in master templates.
• Ability to make judgements within general operating guidelines.
• Competent Knowledge of AstraZeneca Health & Safety requirements applicable to role at the competent capability level.
• Competent knowledge of current GMP requirements and regulatory processes.
• Foundation financial governance (fiscal awareness).
• Good communication skills including cultural awareness.
• Excellent communication and customer relationship skills.
• Strong attention to detail and ability to accurately document test procedures and results.

Desirable Skills/Experience:

• Education in a scientific discipline at degree level.
• Understanding of the Supply Chain activities and processes.
• 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.

At AstraZeneca, we are driven by our commitment to quality. Our work is crucial and valued, as we strive to add real value throughout the lifecycle of our products. We innovate continuously, trialing the latest models and technologies to enhance reliability and excellence in our processes. Here, you will feel empowered to make decisions that put patients first, supported by a proactive, science-based approach. Our collaborative environment fosters strong communication and teamwork, ensuring we deliver our pipeline sustainably, reliably, and safely.

Ready to make a difference? Apply now to join our team!

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!