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Contact Info
Alan O'Riordan
Life Science

+353873657522
[email protected]
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Details

QA Specialist


Reference:AOORAFDX-685010 Location: Cork City
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed

QA Specialist - Cork
Reporting to: Head of Quality
Department: Quality

Purpose of Role

  • To prepare, maintain, update and archive all Quality documentation at the company.
  • Ensure relevant documentation is in place to support any quality/manufacturing activity
  • Highlight any GMP oversights or issues
  • Provide QA support to relevant personnel on how to address any GMP issues as required
  • Follow up to ensure that any GMP issues are addressed appropriately
  • Coach/train relevant personnel on quality issues and provide feedback as necessary
  • Assist with the continuous improvement of quality systems including streamlining GMP related systems site wide

Responsibilities
  • Maintain all site Quality documentations systems
  • Train relevant personnel on DCC
  • Continuously challenge and improve current systems
  • Ensure audit ready at all times
  • Manage quality documents from generation to storage and liaise with relevant personnel on site and off site
  • Perform Annual Mock Recall
  • Develop and maintain a process for status of all End Product Batches/Finished Goods Batch documentation for selection of blends for supply of product to the market
  • Liaise with Production personnel
  • Review End Product Batch and Finished Goods Manufacturing records to ensure consistency across the documentation and GMP compliance.
  • Responsible for the QA approval/release of End Product Batch Manufacturing Records using SAP System.
  • Responsible for QA approval of Finished Goods Manufacturing Record in preparation for shipment of Finished Goods.
  • Generate, record, check & distribute End Product Batch Manufacturing Records & Finished Goods Manufacturing Books, filing & archival.
  • Print Protocols & Reports, Validation document issuance
  • Filing & archiving of Validation Documents
  • Filing of completed periodic reviews of validated systems
  • Liaise with shipping Company & specific customers
  • Generate documentation for shipment to Materials/Finance using SAP system
  • Generation of documents for customers using SAP system
  • Front line supply contact/support for all Finished Goods shipments to the customers

General
  • Assist in preparation of training packages for internal SOP training
  • Printing of Forms eg, , Deviations, Utilities, Training
  • Printing of Logbooks
  • General aid to personnel in once off projects eg, Visio graphs, Power Point Presentations, helping with word/excel documents formatting etc.
  • For new project consisting of new SOP’s, BMR’s, Work Instructions, Validation Documents & Misc docs associated with the campaign
  • Maintain current index and filling of all associated documentation
  • Maintain Site Training File
  • Participate in Site Quality Council
  • Participate in weekly Tiered meetings
  • Support continuous improvement initiatives
  • Development of site personnel in DCC/Quality awareness

Requirements
  • BSc in relevant area
  • 3 years quality experience
  • Perform GMP Self Inspections as required per the Inspection Schedule
  • Perform Vendor Inspections as required per the Inspection Schedule
About You
  • Working knowledge of Microsoft word
  • Basic knowledge of Excel and Powerpoint
  • Good Quality Mindset
  • Excellent interpersonal skills
  • Good communication skills
  • Ability to influence without authority
  • Hardworking
  • Self-motivated
For more information contact Alan O'Riordan on +353873657522 or [email protected]