Production Operator

2 weeks ago

County Dublin, Ireland Xeolas Pharmaceuticals Full time

Reporting to:Production Supervisor Role Function: Part of the Xeolas operations team to perform manufacturing process and projects in line with the company strategy. Responsibility manufacturing operations ensuring product manufacturing is performed according to cGMP, ICH and EHS guidelines. Working Hours: Work 16/5 shift pattern Responsibilities: Execute the production schedule / plan on a day-to-day basis to meet production forecast and the required output. Perform daily / weekly /monthly internal calibrations and verification checks ensure all documentation is complete in a timely manner. Provide Technical support for troubleshooting equipment and process activities. Complete BMRs, logbook entries and any required GMP documentation to cGDP. Prepare, review and approve BMRs, SOPs and logbooks. Perform logbook reviews to ensure all documentation is in line with ALCOA ++ Principles and audit ready. Record and update production metrics. Ensure all training is performed in full and completed in a timely manner. Ensue all tasks performed are compliant with cGMP and EHS guidelines. Work as a team to support, develop and encourage collaboration with all departments to work as one team on site. Ensure all assigned warehousing activities and procedures are adhered to. Ensure all production deviations are raised with Production Supervisor / QA immediately. Support Root Cause Analyse for all quality deviations within the production areas, complete assigned CAPA actions within the designated timeframe. Support R&D activities in the GMP production area when required. Support the creation of EHS task risk assessments within the production areas. Support lean six sigma initiatives on site. Engage in continuous improvement processes / ideas on site. Physical Aspects Manual Handling / lifting requirements of raw materials up to 25kg. Movement, pushing, pulling and handling of large bulky equipment items with the aid of trolleys, dollies and pallet trucks. Continuous standing and operating of equipment for prolonged periods of time up 7 hours per 8 hour day. Repetitive manual operations (dispensing of powders from drums, from a low height, lending bending requirements to ensure all materials are removed). Repeated twisting and movement while operating equipment. General cleaning requirements mopping, wiping down surfaces at both high and low levels, cleaning of equipment. Movement of material and equipment from the ground floor to the seconds floor movement up 6 flights of stairs. Principal tasks / deliverables: Planning/Output Working with the Production Supervisor / Manager to achieve yearly output target. Working as part of operations team to achieve target yields and identify key areas for improvement. Identify any schedule conflicts with the Production Supervisor and determine path forward. Organisation Ensure all training is completed within a timely manner and is fully documented as such. Engagement with Lean Six Sigma projects and objectives with a particular focus on batch manufacturing processes. Ensure Visual management is in place within the production department and that metrics are being updated in a timely manner. Implementation Implementation of overall day-to-day production plan to ensure reliable supply of product within GMP requirements. Ensure all batch records are completed as per GMP requirements. Tracking Progress Update of production metrics on a regular basis to ensure yields for batches are tracked and recorded in a timely manner. Quality Improvement Continuous review of operational processes within the manufacturing area and ensure they aligned with cGMP practices. Ensure that there is no batch rejections or reworks due to negligence or poor GDP/GMP issues. Working with the Production Supervisor to identify any quality issues and highlight to Quality department immediately. Raise deviations as required, and work with the Production Supervisor during any investigations, root cause analyse or CAPAs as required. R&D Support R&D activities in the GMP production area when required. Support R&D in implementation of commercial manufacturing processes for new products. EHS Read and understand all production task risk assessments. Adhere to PPE requirements as part of Processing activities, encouraging safety for yourself and your colleagues. Raising EHS incidents, accidents and near misses and reporting such to EHS officer immediately. Where possible minor issues should be resolved immediately by operator (water spills, trip hazards, etc) Personnel / Recruitment /Talent Management Assist in the recruitment of staff as necessary.

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