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Employer Careerwise Recruitment
Job Title Compliance Specialist (Automation)

COMPLIANCE SPECIALIST (ENGINEERING / AUTOMATION) required by CareerWise Recruitment for our Limerick based Biotech client. Initial 12 month contract on offer.

The COMPLIANCE SPECIALIST (ENGINEERING / AUTOMATION) will have responsibility for ensuring compliance with all aspects of Quality in Automation/Engineering.

* Assist in the creation and management of deviations, change controls, CAPA's etc.
* Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
* Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
* Coordinates with other departments or outside contractors/vendors to complete compliance tasks.
* Assist in regulatory audits and communicates company's automation compliance policies.
* Assesses company's computer systems and identifies any potential Part 11 or Annex 11 gaps and ensure best data integrity practices are enforced.
* Possesses an understanding and experience of principles with good working knowledge of GAMP 5, ICH Q7A, FDA parts 210 and 211.
* Technical writing experience.
* Generation/maintenance of the departments compliance documents.
* Strong attention to detail and accuracy.
* Experience in risk assessments in relation to compliance investigation activities.

* Requires BS/BA in Engineering, Chemistry, or Life Sciences
* With 2 years of related experience within the fields of automation/engineering and biotechnology; will substitute relevant experience for education.
* Experience with process control systems is an advantage but not necessary

Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin.

Supporting Business Demands & Growth since 1999

CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times.

This job originally appeared on
Location Limerick
Date Added 75 days ago
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