Senior Quality Specialist (Quality Systems)


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https://www.teamhorizon.ie/job-search/193-senior-quality-specialist-quality-systems/quality/dublin/job2021-07-05 09:39:531970-01-01Team Horizon
Job TypeRemote
AreaDublin, IrelandDublinIreland
SectorQuality
Start Date
AdvertiserAshling Guthrie
Job Ref#2109
Job Views512
Description
We have an exciting fully remote opportunity available for a Senior Quality Specialist (Quality Systems), with our client who are a leading biopharmaceutical company. This position will support the global Deviation & CAPA process and a network of Subject Matter professionals to assure Deviations & CAPAs generated are controlled, effective, and efficient. Reporting to the Global Process Owner Deviation & CAPA, this position sits in Corporate Quality Systems and is part of a very versatile team. This is a remote role and includes flexible working hours to support our client’s global footprint.



Why you should apply:



  • Join a progressive company with state of the art working facilities, which include an onsite gym and flexible working conditions such as flex hours and WFH


  • There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.


 

What you will be doing:



  • Own, review and approve SOP’s and other GDP/GMP documentation and records, ensuring that Corporate, Site and Regulatory requirements are met.


  • Support the global network to cascade requirements and QMS architecture to company sites and functions


  • Execute the global deviation trending process and collaborate with company sites & functions in the identification, investigation and mitigation of holistic trends


  • Leads or partners with network SME’s on continuous process improvements and on key initiatives


  • Authors, reviews or approves global procedures, documentation and training material


  • Owns or provides QA oversight for Deviations, CAPAs or Change Controls related to the global process


  • Generates and monitors global process health metrics


  • Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.


 

What you need to apply:



  • Degree educated with 7+ years of experience in a pharmaceutical/drug/device manufacturing environment


  • Well-rounded knowledge Quality Management Systems, especially Deviation & CAPA


  • Understanding of Device / Combination Product Regulations


  • Strong organisational, communication, coordination, and meeting facilitation skills


  • Independent, self-motivated, organized, able to multi-task across a global network


  • Cultural awareness and dexterity


  • Innovation mentality with aptitude for developing ideas into measurable objectives


  • Experience with collaboration tools such as Teams, Smartsheets, Miro etc.


  • Project Management and Data Analytics


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