Job Descriptions

Key responsibilities for this role include:

• Responsible for performing analysis on raw material, intermediates, in process or finished product analysis in line with cGMP.
• Analyse other materials as required including samples relating to investigations, development, stability, cleaning, or technical transfer when requested.
• Sampling of materials when required.
• Analytical data, analytical reports and performing peer reviews.
• Make recommendations on the disposition of raw material, intermediates, in process materials samples and prepare support documentation.
• Highlight any planned changes to the testing plan and assess impact of these changes, escalate identified risks to QC PCT Lead as appropriate.
• Sustain IMEX program in the QC team which includes the following ecosystems. o SWP, CI, TPM, Structured Gemba, 5S program.
• Act as SME for assigned IMEX Element.
• Develop constructive working relationships with key members of the QC and supporting teams.
• Participate and seek opportunities in the areas of Right First Time and Continuous Improvement.
• Complete safety and Laboratory investigations, as required (Method 1 and PHP).

The minimum qualifications for this role are:

• Bachelor of Science Degree in a related science or engineering discipline.
• Minimum of 3 years relevant experience in a pharmaceutical laboratory.
• Extensive experience in a laboratory Quality Control environment.
• Experience of pharmaceutical laboratory, with direct experience in QC sampling and testing would be an advantage.
• Clear communicator and able to make clear reasoned decisions under pressure.
• Experience of front-line regulatory interaction (e.g., IMB, FDA).
• Effective problem-solving skills.

Skills

Experience

• 3+ years