- Reference: CJ44073
- Job Type: Contract
- Location: Limerick, Limerick City, Munster
- Category: Science, Pharmaceutical & Food
The Senior Compliance Specialist will report the Compliance Manager for the site with responsibility for the audit program and for managing the site readiness and the execution of External Inspections.
- Supports and owns the review and approval of investigations and corrective action plans arising from internal/external audit observations to assure that they meet the required site and MD&D standards of investigations, corrective action plans and effectiveness checks.
- Responsible for weekly and monthly Reporting of Site Compliance Performance metrics and tracking and trending of the data. Maintains the manufacturing site compliance dashboard for metric reporting.
- Responsible as a Lead Auditor/Auditor for the execution of Internal Audits in support of the Internal Audit Schedule and report/observation issuance for same where applicable.
- Responsible for preparing the data for presenting departmental materials for Management Reviews.
- Supports the creation, deployment, and maintenance of internal audit schedule and approved auditors list.
- Supports and leads Quality and Compliance projects such as Inspection readiness providing regulatory compliance guidance with regard to some, if not all, of the following areas: medical devices.
- Responsible for supporting where required the logistical planning for Regulatory Inspections, such as FDA, Notified Bodies and other regulatory inspections.
- Supports programs for the on-going monitoring and improvement of the effectiveness of the Quality System.
- Promotes a culture of Regulatory Compliance and Risk Management throughout the organization. Supports departmental and franchise objectives, while adhering to the company Credo, as well as local safety and environmental policy and procedures
Education and Experience
- Bachelor’s Degree – Scientific or Engineering Discipline or equivalent related experience (RAC certification, ASQ – CQA, CQE or SCQE).
- Qualified Quality Lead Assessor and experienced auditor in a Quality regulated environment.
- Minimum of 4 years of working experience in the quality assurance / compliance audit environment required
- Strong knowledge, understanding and application of audit principles, concepts and practices related to quality system regulated by domestic and foreign governments. Experience in managing and implementing robust Corrective and Preventive Action Systems.
- 6+ years of quality assurance/compliance preferred.
- Experience managing External Regulatory/Notified Body Inspections (e.g. FDA, Anvisa, Florida DoH, BSi etc.) Ability to influence change.
- Experience with MDSAP certification process would be an advantage
- Experience with Combination Product Regulations and auditing of same would be a distinct advantage
For a confidential discussion and more information on the role, please contact Aisling on 021 4809118 or email email@example.com
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