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QA Specialist - Meath - URGENT - 6 month contract

CplMeath

21 hours ago

Job description

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 experience in GMP. This is an exciting and innovative role with a small team of individuals with a great culture.

Company values are 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 who will contribute to strengthening our Quality Management System and company. The Quality Assurance Specialist will work hand-in hand with our Development Operations Teams, QA Testers, and other stakeholders to deliver a timely, high-quality compliant SAAS product.

Who will love this job?

We believe that this job is for someone who

will take the chance and make an individual impact through autonomy and responsibility
is a self-motivated, multi-tasker, proven team player within cross functional teams
thrives in a start-up environment and can contribute to original ideas
is good at rolling up their sleeves to achieve results in a start-up environment
enjoys Critical thinking / evaluation of process problems skills
who has strong work ethic and the ability to work independently

The ideal candidate should enjoy improving how things are done, as well as making sure they get done

Responsibilities :

Collaboration with the Head of Quality Assurance and other Department Managers to enhance internal compliance, through continuous improvement

Supporting the set up and shaping of our Quality Management Systems

Preparing for our ISO - Certification and maintaining compliance within the ISO framework

Writing and / or review of documentation which support GxP activities for accuracy, completeness, compliance and user friendliness, e.g., SOPs, instructions, validation documentation

Leading, coordinating, or performing deviation investigations

Management / Implementation of Corrective and Preventive Measures, Change Controls and Software Life Cycle Controls.

Providing training to other parts of the business on the Quality Management Systems

Participating in internal and external audits and implementing any resulting recommendations / actions

Reviewing and evaluating customer complaints; supporting root cause determination and risk assessments as necessary

Consideration to General Data Protection Regulation (GDPR) in documentation

To undertake any further duties, from time to time as may be reasonably required

Successful, timely completion of goals and objectives that strengthen the Organisation.

Progress reporting against deadlines

Requirements : Essential

Understanding of relevant quality regulations, such as ISO and GxP e.g., Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP)

At least 3-5 years of experience in Quality Assurance within a regulated industry, particularly in pharmaceutical / life science industries.

Desired :

Knowledge in GAMP, Good Automation Management Systems

Experience in working with quality compliance software and / or Computer Software Validati

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Qa Specialist • Meath