QC System Specialist – APICOM

QC System Specialist – APICOM

Location: Dublin, Ireland

Closing date: 9th February 2025

Competitive Salary and Bonus

Introduction to role:

As a QC System Specialist, you will be responsible for executing Analytical Technology transfers for new small molecule Active Pharmaceutical products from R&D to QC and between labs. You will collaborate closely with other members of R&D, Quality Control Labs, and cross-functional teams.

Accountabilities:

• Execute Analytical technology transfer for new API products from R&D to QC and between Labs.
• Support method validation, qualification, and verification following GMP, ICH, and internal guidelines.
• Prepare Analytical Technology Transfer protocols, summary reports, and supporting documents, ensuring clarity, accuracy, and compliance with regulatory standards.
• Investigate method-related deviations, OOS results, and technical issues by collaborating with cross-functional teams.
• Develop training materials and conduct sessions to enhance competency in newly transferred analytical methods.
• Provide project support to cross-functional multi-skilled teams.
• Support technical evaluation of systems, processes, or analytical procedures.
• Maintain Master Data/specifications in SAP and GQCLIMS.
• Provide QC support for internal and external audits.
• Support change controls and deviations for the QC laboratory.

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 Analytical Technology transfer and Method Validation.
• 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.
• 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 QC 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 a pioneering spirit that encourages us to take accountability and make bold decisions. We partner with product and process experts to ensure excellence across our Quality network. Our work is valued and impactful, as we certify every batch with a personal stamp of approval. We are constantly innovating and trialing new models and technologies to improve our processes. Here, you will feel empowered to follow the science and make decisions that put patients first. Our inclusive community fosters collaboration and camaraderie, making it an exciting place to grow your career!

Ready to make a 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 authorisation and employment eligibility verification requirements.