Compliance Specialist - CGMP - Cork

Company: Confidential
Your Application: You have not applied yet
Location: Cork, Irlanda
JOB DESCRIPTION

Job Overview

Joining a world leader in delivering digital transformation solutions, the Compliance Specialist will be responsible for implementing Confidential practices that will ensure compliance with our Clients Quality Standards and increase efficiency and consistency of the validation process.

Experience working in a pharmaceutical API manufacturing operation is desirable.

Responsibilities:

Ownership and Responsibility of Computer System Validation documentation in line with our Clients Quality Standards and Practices working directly with System Administrators/Subject Matter Experts and Quality Assurance Representatives
Lead procedural improvements that will increase efficiency and consistency of the validation process
Identify Data Integrity and compliance risks, develop a control strategy systems, procedures, training and assess effectiveness through monitoring & governance.
Modify and Review existing CSV & Compliance documentation focusing on continuous improvement and following up on gaps or discrepancies
Work directly with Lab Validation Engineers, System Administrators/Subject Matter Experts and Quality Assurance Representatives ensuring ongoing compliance with our Clients Quality Standards and Practices
Support and participate in site audits

Requirements:

Minimum 5 years experience in a compliance role
5 years' experience technical writing in a regulated environment
Strong knowledge of cGMP is required to understand
the quality systems on-site.
Self-Motivated. Take initiative to identify and drive improvements
Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally
Self-motivated, detail-oriented and excellent organizational and time management skills

Are you the person we are looking for- We are shortlisting now so please APPLY via the 'Apply' button below

Not Ready to Apply--- Feel free to reach out to me James Roche for a confidential discussion on 6029427 or . at

Apply Today

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JOB TYPE
Work Day: Full Time
Employment type: Permanent Job
Salary: Negotiable


JOB REQUIREMENTS
Minimal experience: No experience



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