Pharma QC Analyst – GMP Lab & Method Validation

Collins McNicholas Recruitment & HR Services Group; Dublin; On-site; EUR 42,000 - 62,000; Full time

Job summary

Collins McNicholas Recruitment & HR Services Group is assisting a global specialty pharmaceutical company based in Dublin to hire a Quality Control (QC) Analyst for their expanding team. This is a lab-based role focused on performing and supporting laboratory testing activities in a regulated environment.

The QC Analyst will perform routine QC testing, draft and maintain documentation, participate in method transfers, and support investigations into OOS/OOT results.

Qualifications

• Minimum BSc in Science or a relevant scientific discipline.
• At least 3 years’ experience in a similar laboratory role, including experience within a Quality Control environment.
• Practical experience with analytical laboratory techniques, including LC-MS/MS and GC preferred.
• Experience in analytical method validation and/or method development.
• Experience in pharmaceutical manufacturing, drug development or process development is desirable.
• Experience working within a regulated laboratory environment, with an understanding of applicable quality and compliance requirements.

Responsibilities

• Perform routine QC testing of raw materials, intermediates, finished products and stability samples.
• Draft, review and maintain controlled documentation, including SOPs, protocols, training materials, investigation reports and other QMS documents.
• Participate in analytical method transfers, method validation and method development activities.
• Conduct, document and support investigations into OOS and OOT results, ensuring appropriate escalation and follow-up.
• Support the day-to-day operation and organisation of the QC laboratory, ensuring equipment, materials and resources are maintained in a suitable state for use.
• Apply analytical techniques including wet chemistry, GC and HPLC, with the ability to learn additional techniques.
• Manage testing activities in line with the facility’s testing schedule, stability programmes and operational priorities.
• Ensure laboratory activities are performed in accordance with approved procedures, data integrity requirements, good documentation practices and applicable regulatory standards.
• Maintain accurate, complete and traceable laboratory records and ensure results are documented and reported in a timely manner.
• Work collaboratively with cross-functional teams to support manufacturing, process development, investigations and continuous improvement activities.

Skills

Analytical skills

Communication skills

Attention to detail

Education

BSc in Science or relevant discipline

Tools

LC-MS/MS

GC

SAP

Empower

Job description

Collins McNicholas Recruitment & HR Services Group is assisting a global specialty pharmaceutical company based in Dublin to hire a Quality Control (QC) Analyst for their expanding team. This is a lab-based role focused on performing and supporting laboratory testing activities in a regulated environment.

The QC Analyst will perform routine QC testing, draft and maintain documentation, participate in method transfers, and support investigations into OOS/OOT results.