Quality Batch Releaser

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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 Sandyford Compounding Unit.

*This is a 1 year Fixed Term Contract.*

* The Role:*

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


* 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


* 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

*This is a 1 year Fixed Term Contract.*

**Job:** **Quality*

**Organization:** **Global Quality – Global Compounding Quality*

**Title:** *Quality Batch Releaser*

**Location:** *Ireland-Dublin-Dublin*

**Requisition ID:** *1900005F*