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

4 Day nightshift, 10pm to 8am, Monday night to Friday morning.


Works closely with manufacturing staff on a night-shift to ensure the unit meets customer expectations on delivery and product quality.


Responsible for release of product from the system on the night-shift.


Responsible for supporting production in the review operations.


Responsible for implementation and management of the Baxter quality system within the compound unit. Ensuring regulatory compliance.


Ensure that unit is compliant with all corporate quality system policies and procedures.


Responsible for review of the implementation of the Baxter Quality System to initiate, and drive continuous improvement

Role Responsibilities

Post Compounding check and Release


o Responsible for the Review of prescriptions on Merlin


o Responsible for release activities associated with products manufactured at the compounding units.


Validation


o Management of the site Validation Master Plan


o Ensuring all equipment used for the manufacture and storage of product is validated before use


o Ensuring all equipment used for the manufacture and storage of product is re-validated as required per the validation master plan.


GMP and Facilities and Equipment Control


o Ensure that a schedule of environmental monitoring is in place that complies with GMP and that any out of limits or alerts are investigated and actions taken to correct.


o Responsible for ensuring the schedule of microbiological monitoring ensures the product is safe to use, including ensuring a schedule and facility map are in place and that all testing is complete


o Investigation of out of limits results using exception and CAPA processes


o Ensuring all measuring equipment that may have an impact on product quality are calibrated to traceable standards


Quality System Measurement and Review


o Ensure outcomes, decisions and actions of the review are documented


o Ensure meeting actions are completed to agreed deadlines


o Track and trend on a monthly basis quality system data and indicators, including but not limited to Exceptions, Errors and Complaints. Trending should include timeliness in completion as well as actual numbers


Complaints


o Ensures all incidents reported by customers are appropriately documented and investigated


o Management of complaints using TW8


o Responsible for reporting any complaints that may result in Field Corrective Action immediately to the Business management representative and also the European FCA gatekeeper


o Reporting any adverse events to Pharmacovigilance and the Business management representative


Exceptions


o Ensure that any failure to follow procedure or failure of product to meet specification is fully documented and investigated


o Review and approval of exception reports


o Leading and coordinating investigations in the cause of exceptions


Corrective and Preventative Action


o Monitor all quality system processes to detect need for improvements


o Management of the CAPA system using Track wise software


o CAPA owner and leader


o Ensure CAPA investigations are completed and root cause identified and that appropriate actions are specified and completed according to agreed time frames


o Raising supplier corrective actions to address out of specification raw material issues


o Management of Supplier Corrective Action using Trackwise software


Communication and Training


o Regularly communicates with all site staff regarding quality issues and promotes the quality system as a business process for improvement of customer satisfaction and regulatory compliance


o Ensures staff understand their responsibilities under the quality system regulations


o Communicates changes of the quality system to staff, ensuring appropriate training programs are executed.


Document and Data Management


o Ensures all procedures are controlled and current versions are available to staff as required


o Ensures there are no unauthorized changes to documents including creation of local documentation.


o Ensures all quality records are reviewed and that they are complete, comprehensive and legible and comply with good documentation practice.


Ensures are quality records are retained in such a way that they remain complete, comprehensive and legible

Qualifications

Breadth & Depth of experience 2 years' experience of working in an aseptic compounding operation 12 months experience of quality system implementation Field of expertise: Ideally experience in all or any of the following: Quality system management and implementation Environmental / microbiological control Validation

What are some of the benefits of working at Baxter?

Competitive total compensation package Professional development opportunities High importance placed on work life balance Commitment to growing and developing an inclusive and diverse workforce

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#IND-UKOPS


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Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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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