QC Graduate

<h1><b><b><b>Job Description Summary</b></b></b></h1>To provide Quality Control support during batch manufacture and filling process across the In Process lab.<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><h1><b>Job Description</b></h1><p></p><p><b>MAIN RESPONSIBILITIES</b></p><p></p><p><b><u>Graduate role specific:</u></b></p><ul><li>In Process Testing Support e.g. MET, BU etc</li><li>Running Team DMS Board at Tier 1</li><li>Supporting EM programme</li><li>Consumable management</li><li>5S support</li></ul><p></p><p><b><u>Roles and Responsibilities:</u></b></p><ul><li>Providing QC support during batch manufacture, ensuring turnaround times are achieved as outlined in QC/Production Service Level Agreement and product release times.</li><li>This includes In process Chemistry/Microbiological analysis, finished product Chemistry/Microbiological analysis.</li><li>WFI & Steam sampling and analysis</li><li>Water collection</li><li>Actively involved in Investigations e.g. Batch Corrections, EMI, Bioburden etc</li><li>Performing routine instrument calibrations and calibration checks.</li><li>Routine maintenance of equipment</li><li>Ensuring compliance with cGMP, EHS, GxP etc guidelines at all times.</li><li>Entering and approving results on LIMS/MODA & completion of batch documentation</li><li>Assisting with audits and ensuring lab is inspection ready as required.</li><li>Assisting with 5S of In Process Lab.</li><li>Consumable management – ordering, stock take and following up with vendors on expected delivery times etc.</li><li>Supporting logbook review and archiving for In Process.</li><li>Ensure compliance with current pharmacopoeia and all regulatory/company guidelines.</li><li>Interaction with other departments e.g. Production, Engineering, QA.</li><li>Assisting in the training and up skilling of colleagues where possible.</li><li>Liaising with internal and external customers in relation to QC/Production issues</li><li>Any other duties as required by QC PTL and/or designee.</li></ul><p><b>PRINCIPAL QUALIFICATIONS:</b></p><p>A third level Science Qualification</p><p></p><p><b><span>Skills</span></b><b> REQUIRED:</b></p><p>Good communications skills, excellent time management skills, flexibility and agility will be required. Openness to change. Proven ability to work on own initiative and deliver expectations. </p><p></p><p><b>DESIRED WORK EXPERIENCE:</b></p><p>Pharmaceutical experience in a GMP regulated laboratory environment.</p><p></p><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><h1><b><b><b>Additional Information</b></b></b></h1><div><div><div><div><div><div><div><p style="text-align:left"><b>Relocation Assistance Provided: </b>No</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p></div></div></div></div></div></div></div>