Manufacturing Quality Engineer

Location: Kerry - onsite (potential for some hybrid)

Duration: Full Time Permanent

Industry: Pharmaceuticals

Start Date: As soon as possible

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• Oversee GMP compliance in both the manufacturing and maintenance areas of the facility
  
• Provide support to both maintenance and production personnel (Production Manager/Site Engineer) relating to SOP’s (review, update and generation), GMP/Regulatory compliance, H&S compliance etc.
  
• Ensure maintenance program is appropriate for reliable operation of equipment.
  
• Assist with any equipment breakdowns
  
• Assist with selection and implementation of new equipment, methods & techniques.
  
• Follow up on issues identified by equipment owner or via the maintenance Preventative Maintenance program.
  
• Participate, raise, investigate & complete Deviations, Change Controls and TR’s.
  
• Ensure the local maintenance procedures are in line with best practices
  
• Identify & support continuous improvement initiatives to enhance the Maintenance program in the short & medium term to maintain a reliable plant.
  
• Raise PO’s for approval for any recommended capital equipment items that are considered necessary
  
• Review Stores & Inventory levels of critical equipment.
  
• Carry out internal audits and periodic reviews of GMP activities to ensure compliance.
  
• Assist with QA/QC/QP with quality improvements and investigation of customer complaints
  
• Participate in Customer and Regulatory Audits
  
• Monitor Energy usage and identify any possible opportunities to minimise same
  
• In association with Plant engineer, organise external contractors to ensure calibrations, new equipment qualifications etc. are all completed as required.
  
• Identify staff training needs
  
• By conducting walk throughs and in conjunction with Site Engineer and Production Manager, ensure an acceptable level of housekeeping exists in both manufacturing and maintenance areas. xcfaprz
  
• Oversee H&S in association with external service provider
  

1. 
   
2. Must be degree educated in a scientific or similar discipline.
   
3. 3-7 years experience in a similar role
   
4. Ideally come from the pharma industry
   

For more information, please contact Alan on