Senior Quality Specialist (Quality Systems)
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| Job Type | Remote |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2109 |
| Job Views | 512 |
- 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
