Cache of job #13718433

Job Title

Compliance Professional

Employer

CPL

Location

Mayo

Description

Compliance Professional - permanent job in the Mayo area. The Compliance professional will assist the compliance supervisor and manager in the management of key quality system elements including: Deviation management; Change Control Program, Self-Inspection, Vendor Management (selection and approval; quality agreements, audit schedule), Inspection Management: (Coordinate site GMP inspections; Internal site preparation; pre-audit MOH requests; Response/report compilation & issuance; Post audit commitment management); Quality metrics & monthly quality system & Senior Management review meetings; (Meeting preparation and coordination of post meeting commitments; Manage regulatory standard/guidance revision assessments: Coordinate the site quality plan and ensure plan execution: Manage compliance initiatives program: Management of site quality risk management program: (Management of the site QRM improvement plan. Attend risk assessment meetings. Maintain strong relationships with management and colleagues in the business units, support functions and the quality site and global functions. Articulate the necessary quality requirements in a clear, concise and persuasive manner. Work with the Compliance Supervisor and manager on the delivery of the company quality plan and global regulatory requirements for the site. Assess quality implications of new regulatory guidance and implement necessary changes. Manage quality requirements for process changes & new product introductions as deemed necessary. Ensure effective recording, analysis and reporting of quality KPIs ensuring issues impacting quality performance are addressed and drive continuous improvement. Demonstrate active support and involvement in successful progress of compliance initiatives to enhance the site quality program. Represent the company in Ministries of Health inspections as required. Provide quality input as required, providing direction on day to day activities as a member of the site quality team. Foster an environment of continuous improvements for the Compliance area by identifying and implementing efficiencies and quality improvements. Support process changes/ validation projects where Compliance services are required. REQUIREMENTS. Proven track record in a quality discipline in the Pharma/Medical Device environment. Third level Science qualification. Clear understanding of working within a regulated environment. Excellent communication skills. Ability to use sound judgment to make effective decisions within appropriate timeframes. Proven to be self-directed, self-motivated and ability to prioritise competing priorities. Interested in hearing more? contact Annette Murphy on 091 507515 or email your CV in confidence to annette.murphy@cpl.ie. This job originally appeared on RecruitIreland.com.

Date Added

2535 days ago

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