Quality Specialist - County Meath, Ireland - Cpl

Description

Quality Assurance Specialist – 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 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