Snr Quality Systems Associate at Baxter International

Oxford, England, United Kingdom

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, Medical DevicesIndustries

Requirements

Experience with cGMP and “Specials” manufacturing requirements
Knowledge of local procedural requirements and Baxter Corporate policies
Ability to ensure continuous compliance of the UK Compounding business
Experience with Quality Management Systems (QMS)
Understanding of stability studies, product SmPCs, and scientific literature
Experience with temperature excursion management and evaluation
Familiarity with regulatory standards (GMP, GDP, MHRA)
Experience with field actions and product recalls
Ability to liaise with internal and external partners
Collaboration skills with cross-functional teams

Responsibilities

Ensure compliance with applicable GMP, GDP, MHRA, and other relevant regulatory standards
Lead the development, implementation, and continuous improvement of the Quality Management System (QMS)
Review stability studies, product SmPCs, and scientific literature to define compounded product stability data
Assess and document temperature excursion incidents within the Quality System
Own and lead Temperature Excursion Evaluation Tasks, ensuring timely and thorough investigation
Review and approve temperature excursion documentation and provide product disposition assessments
Support the management of stability records in the Pharmacy electronic systems Merlin and Mercury
Raise significant excursions through the nonconformance process
Ensure regulatory reporting of issues to local Regulatory Authorities as required
Lead and coordinate field actions and product recalls in accordance with Baxter procedure
Ensure effective communication and documentation throughout the recall process
Liaise with internal and external partners such as MoH, Baxter Compounding Units, Baxter Commercial and Medical Affairs teams, Baxter Homecare, etc
Collaborate with cross-functional teams to assess impact and implement corrective actions
Lead and raise significant quality issues within the Global Compounding Organization

Skills

Key technologies and capabilities for this role

cGMPQuality SystemsComplianceManufacturingGMPTrainingAuditingProcedural ComplianceData Analysis

Questions & Answers

Common questions about this position

What is the reporting structure for the Senior QS Associate role?

The role reports into the UK Compounding Quality System Manager.

Is this a remote or on-site position?

This information is not specified in the job description.

What are the key responsibilities of this role?

The role involves ensuring compliance with GMP, GDP, MHRA, and other standards, leading the development and improvement of the Quality Management System, and handling stability and temperature excursion management for compounded products.

What is the company culture like at Baxter?

Baxter's culture is driven by courage, trust, and collaboration, with a mission to save and sustain lives. Employees are empowered to take ownership, prioritize quality over quantity, and bring creativity to challenges, always putting patients first.

What qualities make a strong candidate for this position?

Ideal candidates are creative, thorough, heads-down do-ers who embrace challenges, collaborate effectively, handle complex procedures and data, train others, and deliver results quickly without compromising safety or quality.

Baxter International

Provides essential medical products and services

About Baxter International

Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Deerfield, IllinoisHeadquarters

1931Year Founded

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support

Risks

Needle-free injection technology could disrupt Baxter's traditional injection-based therapies.

Shift to home healthcare may require Baxter to adapt its product offerings.

Growing digital health importance necessitates further investment from Baxter to stay competitive.

Differentiation

Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.

Strong focus on patient-centric innovation sets Baxter apart in the healthcare industry.

Baxter's partnerships, like with Ayogo, leverage digital health for improved patient outcomes.

Upsides

Baxter's investment in Medically Home aligns with the growing home healthcare market.

Rising demand for personalized medicine offers Baxter opportunities for targeted therapies.

Expansion in telehealth supports Baxter's integrated healthcare solutions strategy.

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