QC Chemist

Job Description

A QC Chemist is required for a Pharmaceutical site based in North Dublin. This is an opportunity for an experienced analyst to gain significant cross functional experience in this autonomous role.

This role is a step away from routine analysis and will provide experience with Review, Scheduling, Training, Troubleshooting, Continuous Improvement projects and attending metrics meetings.

This company pride themselves on providing a clear career pathway and development plan for each employee, with opportunity for further internal and external training.

Main responsibilities / job expectations

• When assigned complete the analysis or the review of QC data as required for the testing and release of the following materials:
• Raw Materials, In-process intermediate samples, API's, stability samples,
• Microbiological, environmental and cleaning samples. Ensuring that the analysis or review is performed in accordance with approved analytical procedures and is aligned with the production / shipping plan.
• Compile the weekly QC schedule as required, attending the Visual Management board meetings and liaising with microbiology as required for any QC technologist support for PW and EM during weekly schedule.
• When required complete the QC Approval or Rejection of Raw Materials in accordance with test specifications. Assisting in the release of Intermediates through peer review and LIMS disposition.
• Assist in the training of Technologists in QC practices and procedures and review of technologists training.
• Compiling Metrics to display performance for Quality Control Laboratory.
• Additional responsibilities as assigned such as Equipment contracts, equipment related MSCRs, generation / execution of IPS studies.
• Liaise with QA personnel to ensure delivery of QC data in accordance with the production plan.
• Execution of Trackwise workflows for Change control, Unplanned event and OOS records. Completing thorough root cause investigations for OOT/OOS results. Determining appropriate Corrective and Preventative actions.
• Liaise with manufacturing personnel to ensure availability of materials in accordance with the production plan.
• Working to service level agreements (agreed cycle times) for material release and identify laboratory efficiencies to support the customer requirements.
• Inform manufacturing personnel of any potential delays to material release in a timely manner.
• Liaise with warehouse personnel to ensure availability of raw materials in accordance with the production plan.
• Attend meetings for planning of material retests and vendor evaluations
• Inform supply chain personnel of any potential delays to material release in a timely manner.
• Assist in Change Control Activities - Documentation, Process, Equipment, Facility, Computer and Analytical.
• Assist in Validation Activities - Process, Equipment, Facility and Computer
• Completion of SAP PM activities
• Active participation in continuous improvement within the Laboratory, generating and implementing lightbulb ideas and supporting OE initiatives (e.g. 5S).
• Responsible for the adherence to our Site Safety Culture by means of the following mechanisms;
• Responsibilities in the above role are not limited to those described and may evolve or change from time to time.
• Responsible for the adherence to our Site Safety Culture by means of the following mechanisms;
• Ensure Compliance with site EHS systems and procedures e.g. Permit to work Systems, Incident/Accident Investigation procedures etc.

Education / Certifications:

• BSc. In Science

Experience:

• At least 4/5 years relevant experience working with a variety of analytical techniques in a GMP laboratory.
• Experienced in the review of QC analysis and proficient in computerised systems such as Empower, LIMS and Trackwise.
• Extensive HPLC experience including troubleshooting.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.