JOB DESCRIPTION SUMMARY

The QC Analyst is responsible for performing routine analytical testing on Finished Product samples in compliance with current Good Laboratory Practices (cGLP) and Good Manufacturing Practices (cGMP). The role ensures timely turnaround of results while maintaining high standards of accuracy and documentation. Analytical techniques include, but are not limited to, HPLC, Osmolality, Organic and Inorganic Iodine, Thin Layer Chromatography, Free Aromatic Amines, pH, Refractive Index (RI), Trom’s, EDTA, Technical Tests, Extractable Volume, and complaint sample analysis.

REQUIRED QUALIFICATIONS

• A third level Science Qualification or equivalent
• Basic pharmaceutical experience in a GMP regulated laboratory environment.

• 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.