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Qualified Person
CareerWise RecruitmentCork, IE11 days ago
Job descriptionMinimum 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
Job Description
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.
Role of this position
- 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.
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Qualified Qualified • Cork, IE