Baxter
Healthcare
Releaser,QA
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Releaser, QA at Baxter. Skills: Quality assurance, Batch release, Regulatory affairs. Ensure compliance with cGMP, corporate standards, site policies/procedures,. Inspect and release compounded products”
Industry & Context.
Investigations; Root cause analysis; CAPA
What They're Looking For.
Must Have
Degree or equivalent experience in science-related field, Previous experience in a pharmaceutical company or equivalent-type role, Minimum of 2 years’ experience in a GMP regulated aseptic environment
Nice to Have
Pharmacy degree preferable, Experience/qualifications in microbiology/environmental monitoring a distinct advantage
What You'll Do.
Ensure compliance with cGMP
site policies/procedures
Inspect and release compounded products
Review production and batch records for completeness
Liaise with QPs responsible for product release
Perform quality review of orders prior to manufacture
Liaise with Dispatch and customer service to manage
Approve environmental monitoring results
Prepare environmental monitoring trends
Facilitate stability data
Review stability data
Update stability data
Maintain stability data
Participate in cross functional teams on quality issues
Provide support with investigations and resolution of discrepancies
Assure completeness of root cause
Perform investigation of customer complaints / quality defects
Coordinate corrective and preventive action investigations (CAPAs)
Perform corrective and preventive action investigations (CAPAs)
Support introduction of new products (NPIs)
Review qualification/verification protocols/reports
Approve qualification/verification protocols/reports
Review specifications
Approve specifications
Review validation deviations
Approve validation deviations
Review project validation/plans
Approve project validation/plans
Support release of equipment
Support release of utilities
Support release of facilities
Support release of computer systems
Act as key member of Quality Risk Management
Act as key member of Operational Excellence
Promote continuous improvement
Identify continuous improvement opportunities
Implement continuous improvement opportunities
Ensure change controls follow applicable procedures
Maintain a validated state
Coordinate analysis of customer complaints
Assist analysis of customer complaints
Coordinate investigation of customer complaints
Assist investigation of customer complaints
Support trending of investigation/system reports
Support compilation of investigation/system reports
Support trending of customer complaints
Support compilation of customer complaints
Prepare Key Performance Indicators
Ensure inspection readiness
Carry out cGMP compliance area walk-throughs
Maintain visibility on Production and Processing floors
Perform spot checks on product and documentation
Assist in internal audit program
Assist in external audit program
Participate in regulatory audits
Participate in corporate audits
Participate in internal audits
Conduct audits as per internal audit schedule
Review internal audit reports
Approve internal audit reports
Ensure operational instructional documentation are up to date
Ensure operational instructional documentation are compliant
Ensure operational instructional documentation support efficient production
Manage Documentation System
Maintain Documentation System
Manage storage processes
Manage retrieval processes
Manage destruction processes
Train document owners on documentation errors
Provide feedback to document owners on documentation errors
Maintain Merlin Component Files
Maintain Finished Product Codes
Provide back up on control of Quality Documentation
Provide back up on issue of Quality Documentation
Oversee Change Controls
Administer Change Controls
Implement non-conformances
Execute non-conformances
Administer non-conformances
Complete Inventory Management System transactions
Complete additional Quality related tasks
Complete assignments as required by the department manager
Comply with Good Manufacturing Practices (GMP)
Comply with Good Distribution Practices (GDP)
Provide support to other Quality roles
How You'll Work.
Team & Collaboration
Cross-functional teams; Quality Risk Management; Operational Excellence
Process & Methodology
NPIs, Validation
Full Job Description
**This is where** your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. **SUMMARY** The Baxter Healthcare Ltd Compounding Facility in Dublin operates to a Manufacturing Licence awarded by the Health Products Regulatory Authority (HPRA). A Quality Batch Releaser is responsible for carrying tasks pertaining to compliance and product quality. Providing quality oversight and ensuring compliance with regulatory requirements. This role is required to collaborate with all relevant departments to ensure that key quality systems are operated and maintained in a compliant manner. This will include batch disposition, documentation management and approval, product record review, investigations, complaints, change controls, audits, stability, and regulatory support. Sterile batch and patient specific products are manufactured using isolator and/or LAF technology and/or CDSC technology in a clean room environment. It is the responsibility of the Qualified Person / batch releaser to ensure that all products released from the Dublin Compounding Facility follow the Manufacturing Licence, Good Manufacturing Practice (GMP), Irish and European Legislation and Baxter Healthcare Ltd Standards. **ESSENTIAL DUTIES AND RESPONSIBILITES** * Ensure compliance with cGMP, corporate standards/Baxter Qual
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