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.

Additional Information