My client a leading Pharmaceutical company now require a Senior QA Specialist - Solid Oral Dose
to join their rapidly expanding team.
The Senior QA Specialist - Solid Oral Dose is responsible for promoting a culture of Regulatory Compliance and Continuous Improvement within the Quality Department and across the site.
This is a permanent role based in Dublin and it comes with a good salary with good benefits.
Responsibilities of Senior QA Specialist - Solid Oral Dose:
Management of batch disposition and material status control activities
Management of the Quality Assurance team in the production facility.
Management of review of Batch Manufacturing Records (BMRs).
Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs
Co-ordination of the Change Control process associated with production, ensuring controlled implementation of all GMP related changes
QA oversight of routine manufacturing, testing and relating activities to ensure ongoing cGMP compliance
Ensuring effective participation of the Quality Assurance team in production and other site meetings
Implementation of Key Performance Indicators within the Quality Assurance area to align with company and global quality objectives
Participation in the site Internal Audit programme
Participation in the preparation of, and hosting, external cGMP audits, e.g. from Regulatory Authorities and Global Quality
Participation in the preparation of documentation for regulatory submission and participation in regulatory affairs discussions
Taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement
Implementing efficiency improvements in Quality Dept on a continuous basis and participating in site projects and initiatives
Communication and liaison with other departments on Quality issues (as required), providing guidance and support to others
Motivation, training, discipline and appraisal of Quality Assurance staff.
Acting as a designee to the Quality Assurance Manager as required
Requirements of Senior QA Specialist - Solid Oral Doset
Primary Degree in a scientific discipline
Minimum of 5 years' experience in the pharmaceutical industry in a Quality role
Experience in solid oral dose manufacturing
QP qualification is desired
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