Cache of job #13898211

Job Title

Qualified Person

Employer

Careerwise Recruitment

Location

Limerick

Description

A Qualified Person (QP) is required by CareerWise Recruitment for our Limerick based biotech client. Please call Brian Flynn today for further information on 021-4297423 or email: bflynn@careerwise.ie. THE ROLE: * Manages the batch disposition process to ensure timely release of products. * Ensures the batch disposition process maintains compliance with site practices & regulatory requirements. * Disposition of products & materials in accordance with directive 2001/83/EC and Annex 16, EudraLex, Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. * Support major investigations, ensuring all product deviations are closed prior to batch release. * Reviews and approves Product Quality Reviews. * Reviews and approves new and revised master manufacturing records. * Participates in cross functional teams as Quality/Qualified Person representative. * Participate in third party/supplier audits, as required. * Provide additional QP support to quality related issues, as required. REQUIREMENTS: * Qualified Person status achieved with min 3 years of relevant work experience acting as a QP, named on a Manufacturing and Importation Authorisation (MIA. * Biologics manufacturing experience desirable. * Aseptic / Sterile Drug Product manufacturing experience desirable. * Experience with IMP's (Investigational Medicinal Products) desirable. In Search of Excellence. Specialists in the recruitment of Senior Management, Operations, Technical/Engineering, Senior Supply Chain & Quality personnel, Supporting Business Demands & Growth since 1999. This job originally appeared on RecruitIreland.com.

Date Added

2139 days ago

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