QP & Quality Manager Compounding Sandyford at Baxter International

Dublin, County Dublin, Ireland

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, PharmaceuticalsIndustries

Requirements

Eligibility to work in Ireland on a full-time basis
Bachelor’s degree in pharmacy or a science-related field
Certification as a Qualified Person (QP) following EU GMP standards or an equivalent qualification
6-10 years of experience in Quality implementation within the Pharma industry
Proven knowledge or experience with applicable regulations and standards, particularly EU GMP Annex 1, related to aseptic manufacturing environments
Proven experience in aseptic manufacture with knowledge in sterility assurance and risk management
Demonstrated leadership experience with a track record of meeting results
Ability to thrive in a fast-paced environment and prioritize multiple tasks
Proven ability to manage and supervise a large and diverse team
Strong leadership skills to motivate teams and guide the organization toward quality objectives
Excellent organizational skills for managing tasks

Responsibilities

Guaranteeing that the compounding site meets Good Manufacturing Practice standards for Medicinal Products for Human Use, as outlined in Eudralex Volume 4, including Commission Directive 2003/94/EEC, its amendments, and Baxter company rules
Implementing the quality management system and coordinating the release process of compounded products, ensuring adherence to regulatory requirements, relevant specifications, and customer needs
Communicating with regulatory agencies (HPRA) regarding Manufacturing Licences, GMP inspections, and any compounding product quality-related issues
Leading the audit process for the facility, ensuring the site team is prepared for audits, and investigating and addressing audit findings promptly
Measuring and analyzing site quality metrics and their performance versus targets, and driving continuous improvement of processes and products through relevant indicators
Developing and implementing risk management strategies to ensure process risk reduction and patient safety
Coordinating, performing, and approving quality documents and records for the site, including nonconformance investigations, CAPA plans, change controls, SOPs, validation protocols, and reports
Supporting facility projects, including process development and quality improvement initiatives
Promoting a culture of quality awareness and dedication among all site staff, consistently advocating for quality culture
Defining QA goals for the site in accordance with Baxter's organizational framework
Managing local QA resources and QP, measuring their performance, and providing necessary training and development

Skills

Key technologies and capabilities for this role

GMPEudralex Volume 4Quality Management SystemQPRegulatory ComplianceHPRAAuditsCompoundingGood Manufacturing PracticeManufacturing Licences

Questions & Answers

Common questions about this position

What is the location for this QP & Quality Manager role?

The position is based in Sandyford, Dublin, Ireland at the compounding site.

Is this a full-time position?

Yes, this is a full-time employment opportunity.

What are the key responsibilities of the QP and Quality Lead?

Key responsibilities include guaranteeing GMP standards, implementing the quality management system, communicating with regulatory agencies like HPRA, leading audits, analyzing quality metrics, developing risk management strategies, and promoting a quality culture.

What is the company culture like at Baxter?

Baxter's culture is driven by courage, trust, and collaboration, with colleagues united by the mission to Save and Sustain Lives, empowering individuals to take ownership and deliver exceptional results.

What qualifications are required for this role?

This information is not specified in the job description, as the education and qualifications section is incomplete.

What is the salary or compensation for this position?

This information is not specified in the job description.

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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