Quality Administrator
Full Time 1 Year Specified Contract
CityWest
Objective
The purpose of this role will be to provide administrative assistance & support cross functional entities within the Pharma division instilling a culture of GxP & quality awareness within the Quality & Pharmacovigilance Departments & to ensure compliance with the requirement of ISO 9001, GxP regulatory and principal requirements including continuous updating & maintenance of the company’s Quality Management & Pharmacovigilance System.
MAIN DUTIES & RESPONSIBILITIES
Act as Quality Administrator, maintaining an efficient QMS system by logging training records, new procedures, quality records and other quality documentation onto the Q-Pulse system.
Maintain the Quality Management System (QMS) including managing SOPs, Update, review & approve Standard Operating Procedures, Work Instructions and Quality related documentation, as required, troubleshooting the QPulse system and notify colleagues of SOP’s requiring updates
Prepare weekly, monthly, quarterly & annual reports and/or reviews, as required.
Support Quality Agreements Deviations, Risk Assessments, Change Controls & CAPAs, including participation in investigations
Deliver induction and routine training regarding Company Quality & Pharmacovigilance policies and procedures
Communicate any identified gaps to maintain compliance and identify process improvements
Perform the day-to-day activities of Pharmacovigilance (PV) including registration of Adverse Events, Product Complaints and customer complaints ensuring appropriate follow-up with all relevant stakeholders (e.g. supplier, patient, quality team, etc.)
Support in all ISO required activity to ensure continuous maintenance of the company's ISO Standard.
Communicate any identified gaps to maintain compliance and identify process improvements within the organization.
Maintain the highest quality, compliance and safety standards.
Build positive and professional working relationships with all relevant company personnel.
Supports the Company quality team & quality projects as required.
Keeps abreast regarding all aspects of the role i.e. procedures, compliance and regulatory matters.
Perform any other related duties as assigned from time to time based on company needs.
QUALIFICATION, EXPERIENCE & SKILLS REQUIRED:
Third level qualification is preferred but not essential.
Minimum of 2 years’ experience in a similar Quality administration role is preferred but not essential.
Excellent PC skills, including Microsoft applications Word, Excel & PowerPoint, etc.
Knowledge of Q-Pulse considered an advantage, but not essential.
Ability to work in a busy, fast-paced environment.
Demonstrated ability to drive the completion of tasks.
Knowledge of Q-Pulse or similar electronic quality management software is preferred, but not essential.
Experience of working in a GxP or ISO environment considered an advantage, but not essential
COMPETENCIES
Excellent verbal & written communication skills.
Sound attention to detail.
Excellent telephone manner.
Highly organized & efficient - with an ability to multitask and get the job done.
Excellent interpersonal skills - with an ability to positively interact with all relevant personnel.
An ability to prioritise and work under pressure.
Problem Solving
Collaboration & Proactivity
An ability to meet deadlines.
Knowledge of ISO & GxP, industry standards, and pharmaceutical sector.
Uniphar Background
Uniphar Group is a rapidly expanding diversified healthcare services business with a global footprint and a proud heritage in Ireland. Since Uniphar became a publicly listed company in 2019, the Group has grown organically and through a series of strategic acquisitions, which continue to strengthen Uniphar’s international reach. With a workforce of more than 3,000 spread across Ireland, United Kingdom, Mainland Europe, MENA and the USA, Uniphar is a trusted global partner to pharma and medtech manufacturers, working to improve patient access to medicines and treatments around the world.
Uniphar provides outsourced and specialised services to its clients, leveraging the strong relationships with 200+ of the world’s best known pharmaco-medical manufacturers across multiple geographies, enabled by our cutting-edge digital technology and our expert teams. Uniphar is organised into three key divisions: Uniphar Supply Chain & Retail, Uniphar Medtech and Uniphar Pharma
Culture at Uniphar
From our leadership team and across all of our divisions, Uniphar lives and breathes four key culture pillars:
1.We have a People First approach, we do the right thing and take a stand for our people.
2.We foster a strong Entrepreneurial Spirit where Adaptability, Commitment & Resilience is embodied in our way of working.
3.We have a Common Purpose that connects our diversified businesses and people.
4. Finally, Trust is at the heart of how we operate.
Please note that Uniphar is an equal-opportunity employer; we do not discriminate and welcome all responses.
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