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.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 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.
