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QC Compliance Specialist, South Tipperary
Client: Brightwater
Location: South Tipperary
Job Category: Other
EU work permit required: Yes
Job Reference: bb2390f116dd
Job Views: 99
Posted: 03.03.2025
Expiry Date: 17.04.2025
Job Description:
About the Position
Key Responsibilities
* Co-ordinating the Complaints / Quality Defect Reporting Systems
* Consulting with relevant parties, leading/participating in investigations, agreeing appropriate CAPA etc.
* Identifying and communicating to Quality leadership issues that may impact product quality, safety, efficacy, regulatory compliance, or business continuity which have arisen from a supplier or other element of the role.
* Reviewing / leading Investigations / Root Cause Analysis / Quality Risk Management exercises to ensure any such investigations are documented appropriately with relevant CAPA, if necessary.
* Co-ordinating of local regulatory activities including update/ maintenance of the Site Master File
* Co-ordinating of the Supplier Quality Management System, including conducting supplier audits, reviewing supplier documentation, generating / reviewing Quality Agreements, co-ordination of the supplier notification system, conducting periodic reviews of suppliers etc.
* Co-ordinating any site regulatory audit readiness programs, including managing the front room, collating audit responses, agreeing CAPA, etc.
* Supporting QP certification activities (i.e., batch record review, IMP Order authorisation, Product Specification File maintenance, etc.)
Experience/Requirements
* Minimum of a bachelor’s degree in a science / quality -based discipline
* Minimum of 10 years’ experience in a pharmaceutical finished drug product manufacturing environment with working knowledge of EU GMP, US FDA, Other Guidelines/Regulations.
* Excellent knowledge and understanding of current / pending EU GMP and US FDA regulations
* Strong communication and presentation skills (verbal / written)
* A proven self-starter with advanced organisational skills and attention to detail
* Strong people skills, with the ability to work co-operatively and effectively with others to establish and maintain good working relationships.
Remuneration Package
Salary is negotiable depending on experience.
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