Senior Quality Specialist (Quality Systems)
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| Job Type | Remote |
| Area | Dublin |
| 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
