QC Shift Analyst

MS0234 GE Healthcare Ireland Limited; Cork; Hybrid; EUR 42,000 - 54,000; Full time

Job summary

GE Healthcare Ireland Limited is seeking a QC Finish Product Analyst to ensure finished product quality through compliant pharmaceutical testing and documentation. The role combines laboratory analysis, regulatory compliance, investigations, and cross-functional support.

Responsibilities include performing routine analyses (HPLC, osmolality, iodine analysis, pH, etc.), managing LIMS data, supporting stability programs, and contributing to batch release documentation and trend reporting.

Qualifications

• A third level Science Qualification.
• Minimum 1–2 years pharmaceutical GMP laboratory experience.

Responsibilities

• Carry out routine analysis on Finished Product samples ensuring compliance with cGLP/cGMP and that turnaround times are met.
• Assisting in the maintenance of the stability program and active involvement in investigations.
• Logging of samples in LIMS and entering results, ensuring results are within specification and task approval.
• Assist in audits and provide trends/CPV data; develop expertise in analytical testing to solve issues.

Skills

HPLC

Osmolality

Iodine analysis

Chromatography

Education

Bachelors in science

Tools

LIMS

GMP

Job description

Job Description Summary

QC Finish Product Analysts ensure finished product quality through compliant pharmaceutical testing and documentation. The role combines laboratory analysis, regulatory compliance, investigations, and cross-functional support.

• Analysts perform routine tests, including HPLC, osmolality, iodine analysis, chromatography, pH, and extractable volume testing, while meeting turnaround times and cGLP and cGMP requirements.
• Responsibilities include LIMS data management, stability support, investigations, instrument calibration, batch-release documentation, trend reporting, audits, and standard operating procedure control.
• The role requires a third-level science qualification, 1 to 2 years of pharmaceutical GMP laboratory experience, strong communication skills, training support, and occasional overtime.

Job Description Roles and Responsibilities

Carry out routine analysis on Finished Product samples ensuring compliance with cGLP/cGMP and that turnaround times are met. The testing carried out includes but is not limited to: HPLC, Osmolality, Organic Iodine, Inorganic Iodine, Thin Layer Chromatography, Free aromatic amines, pH, RI, Trom's, EDTA, Technical tests, Extractable volume., complaints etc..

Assisting in the maintenance of the stability program Actively involved in Investigations e.g. LIR's. etc.. Logging of samples in LIMS Entering results on LIMS, checking results are within specification and also task approval. Ensure compliance with EHS at all times, actively participate in EHS activities. Perform routine instrument calibration checks at appropriate times. Preparation and control of Standard Operating Procedures and ensuring compliance with cGMP guidelines at all times. Completion of Documentation for Batch Release process. Assisting in the provision of trends, CPV etc.. Assist in audits. Generation/ reporting of Key performance indicators for the group. Be proactive in approach planning for future and implement improvements in an effective manner. Develop areas of expertise in analytical testing in order to solve technical issues. Ensure compliance with current pharmacopoeias and all regulatory/company guidelines. Interaction with other departments e.g. QA, BU, Sterility assurance etc. Keep colleagues informed of current issues and developments as appropriate. Assist in the training and up skilling of colleagues. Reasonable level of overtime will be required to facilitate the business needs. Liaising with internal and external customers e.g., planning/ QA/ BU etc. Carry out additional duties as deemed necessary by your Group Leader/ Supervisor.

Required Qualifications

A third level Science Qualification. Minimum of 1-2 years pharmaceutical experience in a GMP regulated laboratory environment.

Desired Characteristics

Strong oral and written communication skills. Ability to document, plan, market, and execute programs.

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Additional Information

Relocation Assistance Provided: No

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