Cache of job #13971712

Job Title

QA Specialist

Employer

CPL

Location

North Dublin, Dublin North

Description

Key responsibilities; QA support of manufacturing operations through start-up and onto routine commercial operations. Implementation of batch record review process and on the-floor support of manufacturing activities. QA Operations review of events and investigations. Authoring, review and approval of QA-related procedures. Review and approval of functional area documentation. Support the Disposition process for Drug Substance and ensure material availability for Manufacturing through release of raw materials and consumables. Participation in GMP reviews for new facility construction and new equipment support systems. QA support for the development of batch records. QA support for implementation of the (SAP) system including data verification and integration testing for the Quality function. Change control assessment andCAPA evaluation/CAPA close-out. Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements. Support OPEX programs and champion continuous quality improvement initiatives. Requirements : BSc in Science or related discipline with 2 years’ minimum QA or related experience in a pharmaceutical environment. A clear understanding of cGMP requirements for manufacturing and/or systems and compliance. Required to work on his/her own initiative in addition to working as part of a team, and must be open to shift work. Must be able to work across a team matrix in order to meet accelerated timelines. If you are interested or would like to hear more, get in touch at matthew.pluck@cpl.ie , or apply below. This job originally appeared on RecruitIreland.com.

Date Added

1935 days ago

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