Quality Assurance Specialist – Co. Meath – Hybrid – 6 month Contract
A start-up tech company in the pharmaceutical industry has created a new role for a QA Specialist with GMP experience. This is an exciting and innovative role within a small team that values a great culture. GDP experience is essential.
Company values include diversity, integrity, and respect within the workplace. We believe that diverse perspectives and backgrounds foster innovation and drive growth.
Role: We are seeking an experienced Quality Assurance Specialist to contribute to strengthening our Quality Management System and company. The QA Specialist will collaborate closely with Development Operations Teams, QA Testers, and other stakeholders to deliver a compliant, high-quality SaaS product on time.
Who will love this job?
This role is ideal for someone who:
* Wants to make an individual impact through autonomy and responsibility
* Is self-motivated, capable of multitasking, and a proven team player within cross-functional teams
* Thrives in a start-up environment and contributes original ideas
* Is proactive and results-oriented in a start-up setting
* Enjoys critical thinking and process evaluation skills
* Has a strong work ethic and the ability to work independently
The ideal candidate should enjoy improving processes and ensuring tasks are completed efficiently.
Responsibilities:
* Collaborate with the Head of Quality Assurance and other Department Managers to enhance internal compliance through continuous improvement
* Support the setup and development of our Quality Management Systems
* Prepare for ISO 9001:2015 Certification and maintain compliance within the ISO 9001 framework
* Write and review documentation supporting GxP activities for accuracy, completeness, compliance, and user-friendliness, such as SOPs, instructions, and validation documents
* Lead, coordinate, or perform deviation investigations
* Manage and implement Corrective and Preventive Actions, Change Controls, and Software Lifecycle Controls
* Provide training on Quality Management Systems to other parts of the business
* Participate in internal and external audits and implement resulting recommendations
* Review and evaluate customer complaints, supporting root cause analysis and risk assessments as needed
* Consider GDPR in documentation processes
* Undertake additional duties as reasonably required
* Achieve goals and objectives that strengthen the organization in a timely manner
* Report progress against deadlines
Requirements:
Essential:
* Understanding of relevant quality regulations such as ISO 9001, GxP, GMP, and GDP
* At least 3-5 years of QA experience within a regulated industry, especially in pharmaceutical or life sciences sectors
Desired:
* Knowledge of GAMP and Good Automation Management Systems
* Experience with quality compliance software and/or Computer Software Validation
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