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 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 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