Cache of job #13867096

Job Title

Compliance Specialist

Employer

CPL

Location

Limerick , Clare

Description

Provide support to the CMD segment in the performance of audits or audit related activity. Provide regulatory assessments of audit findings and prepare appropriate reports to auditees and management following established procedures. Review and monitor required corrective actions; conduct follow-up activities on required action items. Assist in the preparation and presentation of regulatory compliance training materials for regulatory, quality, technical, and managerial personnel. Providing support for FDA, Health Authority and Notified Body inspections conducted at facility, including readiness activities, front-and back-room participation/management and general inspection support as requested. Serve as company representative during regulatory inspections. Support activities may include actively and directly interacting with inspectors/auditors, obtaining required information, and assisting with corrective action and/or remediation plans, as necessary. Conducts internal and external QSR/GMP/ISO quality system audits and follow-up activities. Assists project teams with identification of quality system requirements to ensure compliance. Acts as liaison with external auditors during third party/regulatory audits. Bachelors Degree - Scientific/Engineering Discipline or equivalent (RAC certification, ASQ - CQA, CQE or SCQE, ISO Lead Assessor. Minimum of 4 years of working experience in the quality assurance / compliance audit environment. Minimum of 4 years auditing experience. Strong communication, organizational, negotiation and interpersonal skills. This job originally appeared on RecruitIreland.com.

Date Added

2228 days ago

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