Ensure that the Quality Systems are current, maintained, promoted and complied with in accordance with cGMPs, ensuring the site is audit ready, while co-hosting all customer and regulatory audits.
Manager of QA Compliance- Pharmaceuticals- Dublin
Reporting to the Quality Director, the primary purpose of the Manager of QA Compliance is to ensure that the Quality Systems are current, maintained, promoted and complied with in accordance with cGMPs, ensuring the site is audit ready, while co-hosting all customer and regulatory audits.
- Maintaining, monitoring and where necessary improving the site Quality Systems.
- Customer complaint logging, investigation and CAPA identification
- Change control review, assessment and documentation in TrackWise
- Vendor non-conformance review and supplier monitoring
- Conduct internal audits, document findings, identify CAPA's and assist other Departments in implementation.
- Assisting in preparation for Regulatory Audits.
- Act as key contact and host for partner audits.
- Assist as appropriate in the audit of external suppliers of raw and packaging materials.
- Ensuring all updates to GMP guidelines are fully implemented on site.
- Prepare periodic reports assessing site compliance for local and corporate management.
- Issue Quality Compliance KPI's
- Tracking, Trending and Reporting of Quality KPIs.
Education and Experience:
- BSc (hons) Degree in a related discipline
- At least 5 years' experience working in a Quality Assurance capacity with the majority of that time in a QA Compliance Position within a pharmaceutical manufacturing environment.
- Experience of Quality systems to include but not limited to Change Controls, Complaints, PQRs, KPI management and Audits is a must
- Excellent technical report writing skills
- Sound problem solving abilities.
- Experience of conducting Internal and/or External audits
- Experience of Quality KPI metric implementation and reporting
- MSc or related post graduate qualification.
- Previous practical experience of tablet manufacturing/ coating, capsule filling etc would be a distinct advantage
- Experience with potent components
- Experience with Continuous Improvements initiatives especially within Quality Systems
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.