Quality Control Analyst

About the Role and Company

Niche Generics Limited is a modest-sized pharmaceutical company located in Baldoyle, Dublin 13, committed to equal opportunity employment. The company offers a competitive benefits package, including a pension contribution, private health care, and flexible working hours. The Quality Control Analyst will report directly to the Quality Control Manager and play a central role in the Quality Control Laboratory, ensuring that raw material, in-process, finished product, and stability samples are analyzed in adherence to relevant specifications and documented according to good laboratory practices.

Key Duties and Responsibilities

• Operate under direction of the Quality Control Manager, following company safety policies, current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP).
• Receive, log, and manage laboratory samples effectively.
• Conduct analyses primarily using High-Performance Liquid Chromatography (HPLC) and dissolution techniques on raw materials, in-process, finished products, stability, validation, and investigational samples.
• Timely and precise recording of analytical results ensuring accuracy and quality.
• Maintain error-free documentation and review colleagues' work to verify correctness.
• Adhere strictly to departmental quality systems on a daily basis.
• Ensure accurate labeling of laboratory reagents and samples.
• Investigate and resolve discrepancies in analytical data, including involvement in laboratory investigations.
• Assist in updating and maintaining laboratory Standard Operating Procedures (SOPs) and specifications to ensure ongoing compliance.
• Provide training to other laboratory staff as required.

Required Qualifications and Skills

• Possess a Bachelor of Science degree in a life science field.
• Have a minimum of 6 months of practical experience working within a pharmaceutical environment compliant with cGLP and regulated by HPRA.
• At least 6 months of hands-on experience with HPLC testing techniques.
• Demonstrate strong attention to detail and the ability to critically assess analytical data.
• Skill in troubleshooting analytical problems and implementing corrective measures effectively.
• Familiarity with validation processes and technology transfers is advantageous.

Citizenship and Eligibility Criteria

Applicants must meet one of the following criteria at the point of job offer:

• Citizen of the European Economic Area (EEA), which includes EU member states, Iceland, Liechtenstein, and Norway.
• Citizen of Switzerland under the EU-Switzerland free movement agreement.
• Non-EEA citizen spouse or child of an EEA or Swiss citizen holding a stamp 4 visa.
• Person with international protection under Irish law or relevant family member with stamp 4 visa.
• Non-EEA parent of a dependent child who is an EEA or Swiss citizen residing in the state with a stamp 4 visa.

Additional Information

This is a permanent, full-time position based onsite in Dublin. Applications are accepted until August 14, 2026, but early closure may occur depending on application volume. No recruitment agencies are involved in this hiring.

Application Process

Qualified candidates should submit their up-to-date résumé to the Human Resources Department at Niche Generics, Unit 5, 151 Baldoyle Industrial Estate, Baldoyle, Dublin 13, or via email at hr@nichegenerics.co.uk.