Quality Specialist

Quality Assurance Specialist â Co. Meath - Hybrid

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

 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 9001-2015 Certification and maintaining compliance within the ISO 9001 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 9001 and GxP e.g., Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP)

·      At least 3-5 years of experience in Quality Assurance within pharmaceutical/life science industries.

Desirable:

·      Knowledge in GAMP, Good Automation Management Systems

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

@LI-SD1