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QA Specialist

  1. Dublin
  1. Contract
Competitive
24265
  1. Compliance / Quality Assurance
Date Posted21 Feb 2020
QA Specialist required to join a global biotech company in Dublin.
  • QA support of manufacturing operations through commercial operations and any new product introductions.
  • 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.
  • QA support for the development of batch records.
  • Change control assessment and CAPA 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.
  • Excellent communication & presentation skills are essential.
  • Excellent time management & organisational skills along with a proven ability to multi-task.
If this is you please apply today.

The candidate must have the rights to work in the location stated in the job advert.

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