Quality Assurance Associate
Dublin, Ireland / Remote, Ireland
Quality Assurance – Quality Assurance /
Full-Time /
Hybrid
Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organisation dedicated to advancing clinical research and transforming lives.
Role Objectives:
The WEP Clinical Quality Assurance Associate will ensure compliance with relevant Good Distribution and Manufacturing Practices (GDP/GMP) for the importation, storage, and supply of medicinal product by utilizing knowledge of the WEP Quality Management System. The role will support the wider Quality team in the completion of day-to-day Quality tasks and may also own and drive designated Quality-related projects and manage client requirements. This role will operate within a dynamic and diverse environment with a range of products, clients, suppliers, and customers.
The Ideal Candidate:
- Proactive and solutions-driven
- Critical thinker
- Cross-functional collaborator
- Adaptable
What You'll Do:
- Ensure GMP and GDP compliance across all regulated activities
- Initiate and contribute to non-conformances, complaints, CAPAs, risk assessments, and validation protocols
- Support investigations and follow up on CAPAs to ensure timely closure
- Maintain and manage Quality records in the QMS, including change controls, complaints, and risk assessments
- Coordinate and support internal audits, regulatory inspections, and client audits
- Provide day-to-day support for quality-related enquiries across the business
- Assist in the creation, review, and maintenance of GxP documentation
- Support or lead the initiation and closure of Change Controls
- Drive and contribute to continuous improvement initiatives within the Quality function
- Generate and analyze Quality metrics and trends for management review
What You'll Need:
- Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
- 0-3 years of experience in a Quality-related role, with practical exposure to GCP activities.
- Familiarity with eTMFs (e.g., Veeva Vault) and proficiency in Microsoft Office.
- Strong organisational skills with keen attention to detail.
- Knowledge of ICH GCP guidelines and relevant regulatory requirements (e.g., FDA).
- Effective verbal and written communication skills.
- Self-motivated and proactive, with strong interpersonal and critical thinking skills.
- Able to manage multiple tasks and deadlines with accuracy.
- Discreet and trustworthy with confidential information.
- Experienced in cross-functional collaboration for investigations, root cause analysis, and process improvement.
What We Offer:
Medical, Dental, and Vision Insurance
Critical Illness Cover
Death In Service x4 of Basic Salary
Salary Sacrifice Pension
Starting 25 Days Annual Leave
Paid Maternity & Paternity Leave
What sets us apart:
WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.
We're Committed to Our Team:
WEP has many initiatives to encourage wellness, growth, development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events and all we do to support our employees.
We're Committed to DEI:
At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth and to embracing everyone's unique identities.
Our services include:
Access Programs
Clinical Trial Services
Patient Site Solutions
Clinical Trial Supply
Market Access and Commercialisation
WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.
WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
