Compliance Specialist-Supply Chain

CPL

Limerick

Compliance Specialist - Supply Chain Job Summary and Essential Functions: Summary: This position will coordinate Supply Chain cGMP compliance for the Supply Chain Department. Essential Duties and Responsibilities include, but are not limited to, the following: • Develop an effective compliance framework for the Supply Chain department through the development and implementation of appropriate compliance related policies and procedures. • Act as a liaison between the Supply Chain Department and onsite quality and regulatory groups to define and address all issues of non-compliance. • Facilitate all reviews and revisions of all Supply Chain Department related SOP's, plans and policies for each group within the Department. • Provide support, information, and assistance to individual groups and supervisors with the initiation, review, submission, and follow-up of documents such as CC's, NOE's, and DNF's, impact statements and corrective action plans. • Participate in investigations and root cause analysis for all Supply Chain Department issues of non-compliance. • Provide tracking and trending for all supply chain and materials management compliance activities i.e NOEs, EOE’s, CAPA’s. • Provide periodic review of Supply Chain Department documentation and records such as logbooks, receiving reports and Dispensing MR’s to assess for compliance with established quality standards, policies and procedures. • Collaborate with other functions and Rensselaer site to support compliance requirements. • Drive proactive compliance environment in the Supply Chain and Materials Management team through completion of self audits, knowledge transfer and education of compliance related items. • Participate in and obtain results of all Supply Chain Department quality and regulatory audits. • Coordinate training for Supply Chain personnel on regulatory and quality topics such as proper documentation procedures and the use of QUMAS. • Follow current good manufacturing practices (cGMPs. Experience and Required Skills: Education and Experience: • BS/BA in engineering or scientific related field with 5+ years of related professional experience in a cGMP environment or in the operation of an industrial facility. May substitute relevant experience in lieu of educational requirement. • Understanding of warehouse operations, temperature control and cold chain logistics in a cGMP environment desirable. • Excellent communication skills with the ability to engage with a diverse range of individuals across all levels of the organization. • Proficient in MS Office (Word, Excel, Outlook, Access and PowerPoint. This job originally appeared on RecruitIreland.com.

2801 days ago