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Manufacturing Operator

Job description

Purpose

Reporting into the Manufacturing Supervisor, you will perform functions related to the manufacture of drug products, such as setting-up, cleaning, operating, and maintaining equipment.

In this position you will adhere to all cGMP compliance, regulatory mandates and quality requirements. You may also be working in a Class C cleanroom environment.

Responsibilities

  • Actively highlight any safety concerns to assist in the reduction of accidents or near misses.
  • Support and adhere to established manufacturing scheduling processes and production targets.
  • Handle raw materials and/or intermediate or finished products according to applicable SOPs.
  • Operate pharmaceutical production equipment, for new and existing technologies, in strict accordance with production batch records, SOPs, and cGMPs. This includes Gowning correctly and wearing of assigned PPE, performing start-up and testing of manufacturing equipment, operating and monitoring equipment, performing in process equipment tests, observing varying conditions and adjusting equipment controls as required, and keeping equipment operating by following operating instructions and troubleshooting basic mechanical and automation issues.
  • Perform AQL sampling.
  • Complete all required production data entries and calculations for manufactured batches on the BMR/PI Sheet/SIC logs with detail and accuracy in real time.
  • Observe established escalation process for issues impacting established production-related Service Level Agreements (SLAs) and/or fulfilment of production goals.
  • Recognize and report to immediate supervisor any process or equipment anomalies and/or deviations from accepted standards.
  • Provide status updates on manufacturing activities and operational challenges according to defined procedures.
  • Perform master cleans and surface cleans of manufacturing equipment and production areas according to established SOPs and SLAs.
  • Execute machine changeovers between batches according to established SOPs and SLAs.
  • Keep work area neat and orderly and observe all safety and compliance procedures.
  • Seek process innovation and continuous process improvement in production area.
  • Complete and conform to all training requirements for job role, including company-required and machine-specific training.
  • Carry out and assist in the ongoing training of new and existing personal as required in the area of manufacture.
  • Can work equally well in a large or small team environment, where communication and feedback between team members and across shifts is critical.

 

Qualifications/Experience Required

 

  • Education: Secondary School Leaving Cert, or equivalent
  • Experience: Exposure to pharmaceutical manufacturing equipment or equivalent
  • You'll need tableting experience e.g. blending/compression/granulation
  • Knowledge and Skills: Basic Microsoft Excel and Word skills; SAP and TrackWise knowledge desirable
  • You’ll need Pharma OSD Experience ideally in any of the areas directly related to tablets/capsules (ie blending, coating, compression, encapsulation)
  • Manufacturing experience is essential with good GMP experience primarily
  • 1/1.5 + years of experience in Pharma

To apply for this position please contact Amanda Reynolds at Sigmar Recruitment T: +353 91 455304 E: areynolds@sigmar.ie

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

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