Description
My Client a healthcare company based in Dublin are seeking a Senior Quality Associate, Supply Chain & Emerging Markets Deputy Responsible Person.KEY DUTIES AND RESPONSIBILITIES:
Responsible for the maintenance of the API EAME Quality system as part of the EAME/WW Quality system, compliant with relevant GxP's, ISO 13485 and relevant local legislation:
*Act as Deputy Responsible Person for ASIL and API where applicable see attached appendix.
*Ensure alignment between local quality SOP's, API EAME regional SOP's and Corporate Standards, Policies and Procedures through review and update as required.
*Responsible for the Document controller functions on CORAL and to provide cover for the archiving administrative function.
*Support the LMS as system administrator (SC) and the share point within API Supply Chain and EAME Region.
*Conduct internal audits of API EAME QMS to evaluate compliance, providing a non-conformance report to Management Team and QA Manager API EAME QMS/ RP.
*Maintain CAPA / Deviation program and initiate Corrective Action plans with department managers as appropriate.
*Ensure all 3PL's maintain SOP's within their Quality Systems that meet the requirements of Allergan's Quality Standard, Policies and Procedures.
*Perform audits on all Supply Chain vendors to validate compliance with Quality System and Service Level Agreements.
*Support GDP compliance of the 3PLs and their transportation sub-contractors to Allergan SOP's relating to the storage, packaging and distribution of products, and legal or Regulatory requirements.
Quality Improvements Initiatives
*Quality facilitator for the Supply Chain department supporting quality improvement initiatives
*Support quality improvements initiatives across the EAME regions as part of regional quality management review.
*Act as QA representative for region on supply chain expansion and compliance projects
*Support Manufacturing and LRD sites for local quality requirements.
*Due to expansion of the Emerging Market in-direct model and extensive changing regulatory requirements there ensure robust due diligence undertaken and updated technical agreements in place.
*Implementation of the falsified medicines directive.
*Ensure obligations from the new Good Distribution Practices incorporated into Quality management system.
* Monitor investigations due to temperature excursions and implementation of the temperature monitoring and shipping project.
Education and Experience:
*The equivalent of 3 years college education (degree) in a medical/scientific related field. At least 3 years experience in quality related or production in the pharmaceutical or medical device industry.
If you are interested contact me Anna Mooney or apply below with an up to date CV.