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