Description

Testing of pharmaceutical substances e.g. raw materials and drug substances in a GMP environment in accordance with ISL procedures and quality systems. Focus will be chromatography analysis, along with a range of other analytical techniques as required.

Key Accountabilities

•  Lead and execute routine and non-routine QC testing in compliance with cGMP, regulatory requirements, and approved analytical methods.
• Serve as a technical SME for chromatographic techniques, including HPLC, UPLC, and GC, with detectors such as UV/Vis, PDA, and MS (desirable).
• Independently develop, optimize, and troubleshoot chromatographic methods, including selection of mobile phases, gradients, columns, flow rates, temperatures, and injection parameters.
• Design and execute analytical method development studies assessing specificity, robustness, linearity, sensitivity, and overall method performance.
• Lead and perform forced degradation and stability-indicating studies to demonstrate method specificity and product knowledge.
• Plan, execute, and review full analytical method validation packages in alignment with ICH Q2 (R2), including:
   
  • Accuracy and Precision
  • Specificity
  • Linearity and Range
  • Robustness and Ruggedness
  • LOD and LOQ
     
• Author, review, and approve method development reports, validation protocols, validation reports, and technical justifications.
• Provide technical oversight for method transfers, analytical lifecycle management, and continuous improvement initiatives.
• Perform advanced data analysis including chromatographic integration, impurity profiling, and data trending.
• Lead or support OOS/OOT investigations, root cause analysis, and implementation of CAPAs.
• Ensure data integrity, high-quality documentation, and strict adherence to GMP, SOPs, and regulatory expectations.
• Support regulatory inspections, client audits, and internal audits as a QC representative.

Mentor and provide technical guidance to junior QC analysts as required.

Qualifications

• Expert-level hands-on experience with HPLC, UPLC, and GC
• Detector experience including UV/Vis, PDA, and MS (desirable)
• Advanced chromatographic method development, optimization, and troubleshooting
• Full analytical method validation execution and documentation
• Impurity profiling, forced degradation, and stability-indicating methods

GMP documentation, data integrity, and regulatory inspection readiness

• Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related discipline (advanced degree preferred).
• 4+ years of experience in a pharmaceutical GMP QC or analytical development laboratory.
• Proven leadership in analytical method development, optimization, and validation activities.
• Strong working knowledge of ICH Q2 (R2), GMP regulations, and data integrity expectations.
• Demonstrated ability to work independently, lead complex analytical studies, and mentor junior staff.
• Manufacturing Practices, Data Integrity and sound knowledge of analytical technologies (HPLC, GC,  KF, IR, PSD, Xray, Wet chemistry)
• Good organizational skills and strong communication – written and verbal
• Team player, flexible to evolving needs with a strong customer service mentality
• Excellent quality and safety standards
• Aptitude in lab computer systems, including LIMS and Trackwise

Additional Info

Additional information

Expected Behaviors:

• Integrity, consistency and flexibility
• Professionalism; with the client, contractors and colleagues at all times
• Compliance with SGS policies and procedures
• Participate in team meetings / Team player
• Strong analytical ability and associated problem solving
• Results and performance driven
• Excellent communication skills, both verbal & written
• Good time management & attention to detail

To apply please submit your CV. 

Company Description

SGS is the world’s leading Inspection, Verification, Testing and Certification company, with over 98,000 employees in 2,600 locations around the world, including 24 labs in the Pharmaceutical sector. We deliver solutions to a wide range of industry sectors in Ireland. In 2021, SGS acquired the International Services Laboratory (ISL) in Ringaskiddy Cork, a centre of excellence for all aspects of pharmaceutical testing. This includes method development & transfer, release and stability testing, stability program management and support of our Scientific Insourcing

We are seeking a highly experienced Senior QC Analyst to provide technical leadership within the Quality Control laboratory, with a strong focus on chromatographic method development, optimization, and validation. The successful candidate will act as a subject matter expert for analytical methods, ensuring robust, compliant, and scientifically sound testing in accordance with GMP and ICH guidelines. This role requires a hands-on analytical scientist capable of independently leading complex analytical activities within a regulated pharmaceutical environment.

We also will ensure the focus on you and your development. You will receive attractive compensation and benefits, with pharma benchmarked salary, performance related bonus, medical insurance, pension, illness income protection and enhanced vacation. This role is working typical office hours, with flexitime arrangements