Senior Quality Specialist (Quality Systems)


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2021-07-05 09:39:531970-01-01Team Horizon
Job TypeRemote
AreaDublinDublinIreland
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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