Overview
This is whereyour 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.
The Quality Systems Associate will provide Quality Systems support to UK and Ireland Compounding organization to ensure that all sites maintain a compliant, efficient Quality Management System (QMS) in accordance with local regulatory requirements for Good Manufacturing Practice and Baxter Global QMS requirements and to manage and act as SME for the Documentation Control process.
Reports into the UK Compounding Quality System Manager.
Responsibilities
* Responsible for the effective management of the UKI Documentation Control process, in compliance with Global and local Regulatory requirements, by quality data monitoring and analysis
* Coordinate the content review of the Global Quality Documents in draft stage and the implementation assessment of Global Quality Documents issued with SMEs.
* Execute documentation reviews as required
* Act as Subject Matter Expert for the Documentation Control process (TcU author and Change Specialist 3) & archiving
* Provides Training support as an SME in documentation control and archiving
* Support the trending, monitoring and reporting of NCR/CAPA/CQI/CPI in TW8 to facilitate Quality Management Review (QMR).
* Support Internal, Corporate, external Regulatory and Customer audits through provision of requested documentation, records and information in a timely manner
* Other duties in support of Compounding Quality Systems as required, including support to Regional/Global Compounding
Experience and Qualifications
Eligibility required: Resident and eligible to work in the UK on a full-time basis.
* English minimum equivalent to RQF Grade 2, EQF Grade 3 or SCQF Grade 5
* At least 2 years’ experience in the pharmaceutical or medical device industry.
* Experience working in a Quality function
* Experience of Baxter systems and processes.
* Bachelor’s degree or higher in Pharmacy, or other relevant scientific discipline, such as chemistry
* Experience in implementing and maintaining quality systems in a regulated environment, including document control, change control, nonconformance management, validation.
* High level of proficiency in IT systems and data analysis and visualization applications
* Experience with other IT systems is advantageous.
Benefits
* Competitive total compensation package
* Professional development opportunities
* High importance placed on work life balance
* Commitment to growing and developing an inclusive and diverse workforce
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 let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
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Unit 1, Stafford Cross Business Park|Croydon|London|CR0 4TU|United Kingdom
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