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QC Compliance Specialist

1 month ago

Nenagh, County Tipperary, Ireland Brightwater Full time

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.