Overview
The Quality Systems Associate will provide Quality Systems support to the 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. This role acts as SME for the Documentation Control process and supports the documentation lifecycle across the UKI sites.
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 Global Quality Documents in draft stage and assess implementation 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) and archiving.
* Provide 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.
Qualifications
* Eligibility: 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
* Support for Parents
* Continuing Education/ Professional Development
* Employee Health & Well-Being Benefits
* Paid Time Off
* 2 Days a Year to Volunteer, 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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