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  • 1 month ago

jobs description

LSC have a great contract opportunity for a Senior Specialist- Quality Systems to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming therapeutic products.

About The Project - Key Responsibilities
• Provides guidance to global GMP/GDP business partners to support compliant and timely execution of quality management systems (QMS) records such as deviations, investigations, CAPAs, change controls and laboratory investigations.
• Integrates knowledge and experience as skilled specialist with knowledge of corporate and industry standards with respect to area.
• Creates and delivers QMS training and coaching (process and technical).
• Creates, owns, and manages deviations, change controls, and CAPA in TrackWise.
• Creates, updates, reviews, approves and implements QMS procedural documentation and work instructions with accuracy and clarity.
• Participates... in inspection readiness activities and internal/external audits and inspections.

• Bachelor's degree (or equivalent) in a technical or life sciences discipline (ex. Chemistry, Biology, Biotechnology)
• 6 years' + experience in Pharmaceutical, Device or Commercial Quality Assurance within the biopharmaceutical or pharmaceutical industry.
• Direct experience with development and approval of deviations, CAPAs, Change Controls and laboratory investigations.
• Prior experience in a Global QA role preferred.
• Experience using TrackWise required.
• Experience using Veeva Vault eQMS desired.

For our contracting positions in Ireland's pharmaceutical industry, applicants must possess a Stamp 1G or a Stamp 4 visa. We apologize for any inconvenience, as visa sponsorship is not available currently. Thank you for your attention.

Apply via this advert or contact Gráinne Hodnett at LSC on 021-4777329 if you have any more questions about this.
• Partners to the world’s top Life Science companies we offer you the best contract opportunities in the industry
• 95% of LSC contracts are renewed letting you choose contracting as a long term career option
• LSC’s Consultant Success Programme focuses on skills development & on-site support to help you achieve your career goals
Dublin Ireland


Apply - Senior Specialist Quality Systems Dublin