A QP is needed by CareerWise Recruitment for our Kerry based pharma manufacturing client.
The qualified person will maintain and develop quality and regulatory standards for all product lines.
THE ROLE: Ensuring that an effective pharmaceutical Quality Management system is operated and that all regulatory obligations of manufacturing are fulfilled Being responsible for disposition of medicinal product Manage communications with and represent the company during Regulatory Inspection.
Support Regulatory inspections and prepare written responses to inspections.
Oversee the team in the review and approval of Non-Conformances, CAPA, change controls and complaints.
Ensure Batch record review to verify compliance with GMP and Market Authorization prior to batch release.
REQUIREMENTS: Minimum of 1 years experience in GMP sterile manufacturing A relevant third level qualification in science or equivalent The QP must be eligible to act as a European Qualified Person (QP), certifying products in compliance with 91/412/EEC , EU2019/6 & Annex 16.
Primarily an onsite role with some flexibility Please call Ken Murphy today for further information on or email: CareerWise Recruitment (In Search of Excellence) N.B.
It is essential that you hold a valid working visa for Ireland Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
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Skills: QP Quality Regulatory