A Quality Specialist is required for a biotech company in North Dublin. The incumbent will support QRM (Quality Risk Management) and compliance activities. The Successful candidate will ensure that objectives are effectively achieved to ensure compliance, safety and reliable supply to their customers.
- Lead various QRM activities required on site.
- Act as QRM facilitator and Risk lead, as applicable.
- Schedule the completion of QRAs and track to completion including tracking to closure associated QRM CAPAs.
- Present QRAs for concurrence at Site QRM Council.
- Support for related Compliance deliverables in support of audits and inspection readiness.
- Support for Change Management activities.
- Provide compliance contribution to project teams and leads small projects.
- Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming company and regulatory expectations and compliance changes/challenges.
Qualifications & Experience:
- Degree in natural or applied sciences (Biotechnology, Pharmacy, Biology, Engineering).
- Minimum 3-5 years’ pharmaceutical and/or biotech industry experience in Quality/ Compliance / Validation related role.
- Experience in startup biotechnology and drug substance facilities a distinct advantage.
- Familiarity with Commissioning & Qualification lifecycle deliverables.
- Sound awareness and understanding of pharmaceutical business, especially with regards to quality, compliance and regulatory requirements.
- Experience in Quality Risk Assessments, as a participant, risk owner/author/facilitator.
- Experience with change controls and deviations.
- Experience in project management with demonstrated problem solving capabilities.
- English fluency written and spoken (the Company language).
To apply for this job email your details to firstname.lastname@example.org.