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Compliance Specialist - CGMP

Job Category:
Analyst (Business/Systems)
Job Type:
Permanent
Level of IT Experience:
5-10 Years
Area:
Cork
Location:
Cork City
Salary:
€30,000 to €59,000 per annum
Posted:
19/09/2021
Recruiter:
FRS Recruitment
Job Ref:
FRS45246

Joining a world leader in delivering digital transformation solutions, the Compliance Specialist will be responsible for implementing best 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 087 6029427 or email me at

Contact Details:
FRS Recruitment
Tel: 00353 877 686 334
Contact: James Roche

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