- Quality point of contact at both a site level and for all external inputs (Transfer Site QA/QC/ Regulatory), including co-ordination of/attendance at Quality working group meetings.
- Participate as functional expert in the cross functional team that manages introduction of products and materials on site.
- Performs quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
- Authors, reviews and participates in approvals of protocols and reports for technology transfer, method qualifications and method validation.
- Review other documentation associated with new product, drug substance and material introduction (Material Packs, QC Test Specifications, BOMs, MES documentation etc.)
- Development & monitoring of supplier performance metrics. Actively participates as a member of Material Review Board and Quarterly Business Review of key suppliers, and other cross functional forums as requested.
- Responsible for supporting deviation and atypical close out and initiating/following up on corrective and preventative actions.
- Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements. Assist in the proactive evaluation of site compliance against emerging regulatory trends.
- Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site.
- Actively participate in Plant/Quality committees and works with other site functional groups, such as the QC, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives.
- Bachelor's Degree or higher preferred; ideally in a related Science discipline
- 3-5 years' experience in a quality role, ideally in a pharmaceutical manufacturing environment.
- Knowledge of regulatory requirements to Irish, European and International Codes, Standards and Practices
- Knowledge of cGMP and GDP
- Report, standards, policy writing skills required
- Equipment and process validation desired
- Proficiency in Microsoft Office and job related computer applications required
- Lean Six Sigma Methodology experience desired
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists