Releaser, QA Job at Baxter (Dublin)

Job Description

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

Job Responsibility

Ensure compliance with cGMP, corporate standards/Baxter Quality Systems (PQS), site policies/procedures, regulatory requirements, and industry standards
Batch Disposition
Inspection and batch release of compounded products under the supervision of a Qualified Person (QP)
Responsible for reviewing production and batch records for completeness and releasing product
Liaising with the QPs (qualified persons) responsible for product release
Performing quality review of orders prior to manufacture
Liaising with Dispatch and customer service to manage quality issues and timely customer service
Quality approval of environmental monitoring results and preparation of trends
Stability
Facilitating, reviewing, updating, and maintaining stability data on the system when required and in accordance with the annual stability review schedule
Investigations
Participating in cross functional teams as required to provide consultative support on quality-related issues. Providing support with investigations and resolution of discrepancies. Assuring completeness in terms of root cause, action taken and CAPA for assigned records
Performing investigation of customer complaints / quality defects
Coordinating and performing corrective and preventive action investigations (CAPAs)
Changes/New projects/Periodic reviews
Supporting the introduction of new products (new product introductions: NPIs)
To review and approve qualification/verification protocols/reports, procedures, specification, validation deviations and project validation/plans as required
Support the timely release of equipment, utilities, facilities, and computer systems following the execution of test protocols
Act as a key member of Quality Risk Management and Operational Excellence to improve efficiencies and to promote continuous improvement. Identify and implement continuous improvement opportunities
Ensure that change controls follows applicable procedures and maintain a validated state
Customer Complaints
Co-ordinate and assist with the analysis and investigation of customer complaints
Metrics
Support trending and compilation of investigation/system reports and customer complaints in a timely manner
Preparation of Key Performance Indicators
Inspection/Audit
Ensure inspection readiness in work completed
Carryout cGMP compliance area walk-throughs of manufacturing as required ensuring site is always audit ready. Maintain visibility on Production and Processing floors and perform spot checks on product and documentation
Assist in the internal and external audit program. Participation in regulatory and corporate / internal audits. Conduct audits as per internal audit schedule
Review and approve internal audit reports
Documentation Management
Ensure that operational instructional documentation (SOPs and batch documentation) are up to date, compliant, and supports efficient production
Manage and maintain the Documentation System. Manage of site archive, storage, retrieval, and destruction processes
Train and provide feedback to document owners on documentation errors for continuous improvement, as well as cGMP compliance
Maintenance of Merlin Component Files and Finished Product Codes
Other
Compilation of reports in a timely manner as requested
Providing back up on control and issue of Quality Documentation
Oversee and administer Change Controls
Implementation, execution, and administration of non-conformances
Complete Inventory Management System transactions as required
Complete additional Quality related tasks and assignments as required by the department manager
Compliance to Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP), as applicable
Training of site personnel (including Quality and Manufacturing personnel)
Provide support to other Quality roles as needed
Compliance to Environmental Health & Safety (EHS) requirements

Requirements

Degree or equivalent experience in science-related field essential
Pharmacy degree preferable
Previous experience in a pharmaceutical company or equivalent-type role. Ideally a minimum of 2 years' experience in a GMP regulated aseptic environment
Experience/qualifications in microbiology/environmental monitoring a distinct advantage
Highly motivated
Meticulous in attention to professional standards
Respond well to time constraints with an ability to work in a dynamic, fast-paced and goal driven environment
Ability to work in a team-based environment with good communication, influencing and interpersonal skills
Ability to manage a wide range of specific tasks
Excellent organisational and coordination skills

What we offer

Pension
Health Insurance
Life Assurance
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

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Releaser, QA

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