Description
Reporting to the Quality Director, the primary purpose of the Manager of QA Compliance at is to ensure that the Quality Systems within their current, maintained, promoted and complied with in accordance with cGMPs, ensuring the site is audit ready, while co-hosting all customer and regulatory audits.Main responsibilities, duties and tasks associated with the role:
- 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.
The Person:
The successful candidate will possess the following qualifications, skills, experiences and attributes:
- BSc (hons) Degree in a related discipline
- At least 8 years working within a pharmaceutical manufacturing environment.
- At least 5 years' experience working in a Quality Assurance capacity with the majority of that time in a QA Compliance Position (similar to the above)
- 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
Ideally the successful candidate would also possess;
- MSc or related post graduate qualification (QP status in not a requirement for this post).
- Previous practical experience of tablet manufacturing/ coating, capsule filling etc would be a distinct advantage
- Experience with CMO management
- Experience with Continuous Improvements initiatives especially within Quality Systems
Not sure yet? No CV call me for more information Anna Mooney .
For immediate consideration apply below with an up to date CV.