Quality Assurance Systems and Validation Specialist

Westbourne IT Global ServicesDublin

On-site Full-time

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Experience Level

Experience

Qualifications

QualificationsThe ideal candidate will possess strong interpersonal, communication, and presentation skills along with excellent organizational and time management abilities. A thorough understanding of quality assurance principles within a pharmaceutical context is essential.

About the job

The Quality Assurance Systems and Validation Specialist plays a critical role in ensuring that all Good Manufacturing Practice (GMP) related changes, systems, and validation processes meet regulatory standards and internal quality benchmarks. This position serves as a subject matter expert in change control, validation, and quality systems, providing support across manufacturing, laboratory, engineering, and IT operations within a highly regulated pharmaceutical setting.

Key Responsibilities

Quality Systems & Change Control

Evaluate the GMP impact of changes in line with site Change Control protocols pertaining to:
- Facilities and utilities
- Laboratory and manufacturing equipment
- Control and automation systems
Ensure that all changes are thoroughly assessed, documented, and approved to guarantee GMP compliance.

Validation & Compliance

Provide expert validation support to ensure adherence to current industry regulations, guidelines, and best practices.
Review and endorse master and executed qualification and validation documentation, including protocols, reports, and supporting data, ensuring alignment with:
- Regulatory requirements
- Standard Operating Procedures (SOPs)
- Specifications and acceptance criteria

Validation activities encompass but are not limited to:

Qualification of premises, equipment, and utilities
Computer System Validation (CSV)
Laboratory equipment validation
Support for New Product Introductions (NPIs)

Capital Projects & Design Review

Review and approve GMP-related design elements of major capital projects, including:
- New facility construction
- Facility upgrades
- New manufacturing equipment and support systems

Cross-Functional Collaboration

Collaborate effectively with teams in Manufacturing, Quality Control, Utilities, Engineering, Automation, and IT.
Engage in cross-functional initiatives as directed by the Quality Systems and Validation Manager.

Regulatory & Quality Standards

Ensure that quality systems are implemented and maintained in compliance with:
- ICH Q7
- EudraLex
- 21 CFR requirements
- Site Quality standards
Support data integrity initiatives, ensuring compliance with GMP data integrity requirements and regulatory expectations.

About Westbourne IT Global Services

Westbourne IT Global Services is a leader in providing innovative IT solutions tailored for the pharmaceutical and life sciences industries. With a commitment to quality and regulatory compliance, we strive to ensure that our clients meet their operational goals while adhering to industry standards.

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Heartstrings Pet Hospice, In-Home Euthanasia & Aftercare

Part-time|Remote|Jersey Village TX

Join Heartstrings Pet Hospice and experience the fulfillment of providing compassionate end-of-life care to pets and their families. As a Part-Time In-Home Veterinarian serving Jersey Village and the Greater Houston area, you will have the opportunity to reconnect with pet families and deliver the quality care you’ve always envisioned, with ample appointment times and limited administrative responsibilities.At Heartstrings Pet Hospice, we understand the significance of supporting pets during their final moments by offering in-home euthanasia services. Founded by veterinarians, we are dedicated to fostering deep and meaningful relationships with pet families, colleagues, and our local community. Join our nurturing environment where you can flourish both professionally and personally.Why Heartstrings Pet Hospice?Make a significant impact with an average of 3-4 appointments dailyReceive heartfelt gratitude and appreciation from familiesEnjoy the flexibility of a mobile practice, free from clinic constraintsAccess comprehensive training and ongoing mentorshipAchieve a true work-life balance with flexible scheduling options (2-5 days per week, with most appointments from 9 am to 5 pm)Engage in team-building activities and retreats

Mar 1, 2026

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