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Batch Releaser

Req # JR - 027082 Location Dublin, Leinster, Ireland Job Category Quality Control Date posted 09/08/2020

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SUMMARY

12 month Contract

The Quality Batch Releaser is responsible for the inspection of all compounded products and their associated documentation prior to their deputy batch release from the Baxter Sandyford Compounding Facility.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The Quality Batch Releaser (Deputy Batch Releaser) is accountable and responsible for the following activities, as relevant:

  • Inspection and deputy batch release of compounded products under the supervision of a Qualified Person (QP)
  • Ensure products and processes comply with procedures and the principles of GMP
  • Liaising with the QP’s (qualified persons) responsible for product release
  • Liaising with Dispatch and customer service to manage quality issues and timely customer service
  • QA approval of environmental monitoring results and preparation of trends
  • Preparation of Deviation and QA trend reports
  • Preparation of Key Performance Indicators (KPIs)
  • Perform investigation of customer complaints / quality defects (PCC delegate - Product complaint Coordinator)
  • Perform quality review of orders prior to manufacture
  • Development of quality system procedures, controlled documents and processes
  • Review and investigation of deviations and reject / scrap reports and the implementation of corrective and preventative actions
  • Coordination and performance of corrective and preventive action investigations (CAPA’s)
  • Review of process change controls
  • Review of validation protocols and reports
  • Maintenance of Merlin Component Files and Finished Product Codes
  • Provide support to the site wide Quality Department
  • Assist in the internal and external audit program. Participation in regulatory and corporate / internal audits and performance of supplier audits (as required)
  • Training of Quality and Manufacturing personnel
  • Compliance to Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP), as applicable
  • Compliance to Environmental Health & Safety (EHS) requirements
  • Refer to BaxWho for organisational structure

    Elements of duties and responsibilities, in terms of routine activities, and specific projects, may span both Baxter Dublin Compounding operations (Sandyford and Deansgrange). All such duties/responsibilities are governed by the overarching Baxter Quality Management System.

    EDUCATION AND/OR EXPERIENCE

  • Degree (or equivalent) in science-related discipline essential
  • Previous experience in a pharmaceutical company or equivalent-type role. Ideally a minimum of two years’ experience in a GMP-regulated aseptic environment.
  • Experience/qualifications in microbiology/environmental monitoring a distinct advantage

SKILLS

  • Good problem solving and investigation skills
  • Good professional standards, meticulous and demonstrates good attention to detail
  • Ability to work under pressure and meet deadlines
  • Highly motivated self-starter and team worker
  • Ability to work in a team-based environment and ability to manage a wide range of specific tasks
  • Good organisational, coordination and communication skills

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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