Quality Assurance Batch Releaser

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

SUMMARY

The Baxter Healthcare Ltd Compounding Facility in Dublin - Sandyford 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 company Standards.

ESSENTIAL DUTIES AND RESPONSIBILITES

• 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.

EDUCATION AND/OR EXPERIENCE

• 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.

SKILLS

• 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 are some of our benefits of working at Baxter?

• Pension
• Health Insurance
• Life Assurance
• Baxter is committed to growing and developing an inclusive and diverse workforce – you can read more about our specific values here https://www.baxter.com/careers/inclusion-diversity.

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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