QC Senior Analyst - APICOM

QC Senior Analyst

Location: Dublin, Ireland

Closing date: 4th February 2025

Competitive Salary and Bonus

Introduction to role

As a QC Senior Analyst for API testing, you will be responsible for performing analytical testing on Active Pharmaceutical Ingredients (APIs), intermediates, and Raw Materials to ensure compliance with quality standards and regulatory requirements. You will work closely with other members of the Quality Control team to execute testing protocols, analyse data, and contribute to the continuous improvement of laboratory processes.

Accountabilities

• Execute analytical test methods for the quality control testing of API samples, including but not limited to HPLC, GC, FTIR, UV-Vis, and KF.

• Prepare and standardize reagents, solutions, and samples for analysis according to established procedures.

• Perform routine maintenance and calibration of laboratory equipment to ensure accuracy and reliability of test results.

• Document test procedures, observations, and results accurately and in compliance with cGMP guidelines.

• Participate in method validation and verification studies to support the development and implementation of new analytical methods.

• Collaborate with cross-functional teams, including Manufacturing, R&D, and Quality Assurance, to investigate and resolve testing discrepancies or out-of-specification results.

• Maintain a clean and organized laboratory environment and adhere to safety protocols and best practices.

• Contribute to the continuous improvement of laboratory processes through participation in team meetings, training sessions, and quality initiatives.

• The role may require shift or on-call work.

Essential Skills/Experience

• B.A. / B.Sc. or equivalent in Biological Sciences, Chemistry or other biotechnical science or equivalent experience in regulated industry.

• Minimum 2-5 years of laboratory experience in a GMP laboratory.

• Proficiency in analytical techniques commonly used in API testing, such as HPLC, GC, FTIR, UV-Vis, and KF.

• Knowledge of cGMP regulations and guidelines governing pharmaceutical quality control.

• Strong attention to detail and ability to accurately document test procedures and results.

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.

At AstraZeneca, we work on diversified tasks with a global team. Partnering with knowledgeable colleagues across multiple business functions allows us to be exposed to new ways of thinking, helping us grow collectively and as individuals. This is a place where every voice is heard and matters. We are committed to innovation, trialling the latest models and technologies to improve reliability and excellence in our processes. Our focus on patient-centricity drives us to deliver medicines safely and efficiently.

Join us at AstraZeneca and make a real difference in patients' lives! 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.