QA Specialist - Meath - URGENT - 6 month contract
QA Specialist - Meath - URGENT - 6 month contract
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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. GDP experience essential.
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
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Quality Assurance
* Industries
IT Services and IT Consulting
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