QC Shift Analyst

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