Qs Associate

**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**

Our Compounding Thetford team have a great opportunity for a QS Associate to join the team. Reporting the Quality Manager, you will ensure continuous compliance of Compounding Unit to cGMP and “Specials” manufacturing requirements, local procedural requirements and Baxter Corporate policies.

**Main duties & responsibilities**
- Execute documentation reviews as required;
- Investigate complaints and monitor CAPAs related to them;
- Support the execution of timely deviations and complaints investigations;
- Ensure timely completion of all Quality System commitments;
- Support the preparation and development of Annual Product Quality reviews;
- Support validation programs and change control activities as required;
- Proactively identify and support implementation of continuous improvement opportunities in QS, QA and Operations;
- Ensure timely completion of all GMP commitments;
- Ensure timely communication of significant GMP and product quality issues to QA Management;
- Comply with EHS/GMP/GDP/Company and Corporate policies and external regulatory requirements;
- Ensure facility and process compliance through attendance of Gemba activities, identifying actions and facilitate implementation;

**Document and Data Management**
- Support the update and implementation of changes to controlled documentation at the site.
- Liaise with the Document Processing Unit to identify and communicate document support requirements to ensure timely issuance of controlled documentation.
- Ensures all local THT procedures are controlled, current and available to staff as required.
- Support alignment and standardisation of documentation across the UK, Ireland and Nordic cluster.

**Quality Management Review (QMR)**
- Support Quality Management Reviews through trending and reporting of applicable Quality Management System metrics and data.
- Identify, track, trend and report Key Performance Indicators (KPIs) for processes under role responsibility to identify opportunities for improvement.
- Track and trend quality system data and indicators, including but not limited to NCR, CAPA, CQI, Complaints, Micro OOL, Service Complaints.
- Support scheduled completion of QMR and cross site Quality Indicator meetings
- Ensure outcomes and decisions of the Quality reviews are documented and actions tracked and progressed in the PQS to agreed deadlines.
- Report weekly / monthly / quarterly quality KPI to Senior Management.
- Support continuous improvement of systems to track and trend quality system data and indicators, including timeliness in completion as well as actual numbers.

**Audit Management**
- Support Internal, Corporate, external Regulatory and Customer audits through provision of requested documentation, records and information in a timely manner.
- Support site’s audit readiness activities
- Participate in the annual internal audit program as required
- Track and trend Thetford unit audit findings

**Complaints**
- Support progression of Complaints in TW8 with assigned Owners and Users to ensure timely closure.
- Support the trending, monitoring and reporting of Complaints data in TW8 to facilitate Quality Management Review (QMR)
- Support update and maintenance of local Complaints procedures and processes in line with Corporate, Compounding and Regulatory requirements.

**Corrective & Preventive Action Processes**
- Support initiation and progression of NCR/CAPA/CQI/CPI in TW8 with assigned Owners and Users to ensure timely closure.
- Review and approve SNCR/NCR investigations and Corrective and Preventive Actions, to confirm completeness and effectiveness of root cause investigations and actions to eliminate repeat occurrences.
- Support the trending, monitoring and reporting of NCR/CAPA/CQI/CPI in TW8 to facilitate Quality Management Review (QMR)
- Support generation of User training materials for TW8 NCR/CAPA/CQI/CPI System Users
- Support update and maintenance of local NCR/CAPA/CQI/CPI procedures and processes in line with Corporate, Compounding and Regulatory requirements.
- Support identification of quality system process improvement opportunities identified through NCR/CAPA/CQI/CPI trends.

**Change Control**
- Support maintenance of effective change control proce