Releaser, QA at Baxter International

Stockport, England, United Kingdom

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, PharmaceuticalsIndustries

Requirements

Understanding of responsibilities under quality system regulations
Ability to deliver training to staff on compliance with Baxter quality systems and country regulations
Proficiency in using Pilgrim PMDA software for complaint management (if required)
Capability to initiate, investigate, own, and lead Non-conformance/CAPA events
Skills in maintaining local change control processes and assessing risks/impacts
Ability to approve validation protocols and reports (if required)
Competence in quality review of environmental monitoring results (if required)
Support for site risk management process and updating risk assessments

Responsibilities

Ensure all product released meets specification and customer requirements
Ensure all product undergoes effective visual inspection, release checks, and compliance with GMP and quality system requirements
Ensure no product is released before formal assessment of deviation impact and approved disposition
Ensure disposition of products and raw materials/components impacted by non-conformances is documented and completed timely
Regularly communicate with site staff on quality issues and promote quality system for improvement
Attend and participate in QA Team meetings and monthly quality review meetings
Complete assigned meeting actions to agreed deadlines
Escalate customer-reported incidents to line management and manage complaints using Pilgrim PMDA software (if required)
Raise supplier complaints with line management for out-of-specification raw materials
Document and investigate failures to follow procedures or product specification issues
Monitor quality system processes for improvements and initiate Non-conformance/CAPA reports
Ensure Non-conformance/CAPA investigations identify root cause and complete actions on time
Maintain local change control process, assess risks/impacts, and support change implementation
Approve validation protocols and reports (if required)
Perform quality review of environmental monitoring results (if required)
Support Environmental, Health & Safety (EHS) programme
Support site risk management process and update risk assessments based on quality reviews and changes
Actively manage risks by identifying potential issues

Skills

GMP

Quality Assurance

Visual Inspection

Product Release

Deviation Assessment

Non-Conformance Disposition

Regulatory Compliance

Quality Systems

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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