Quality Assurance Specialist

Job description

Role: Quality Assurance Specialist

Location: Dublin 15

Job Type: Permanent/Full time

Start Date: As soon as possible

Reports to: Quality Manager

Noel Group are partnered with a unique supply chain management company with a strong service portfolio within the areas of Transportation, Refrigeration, Storage and Value-Added Services. They are renowned for delivering innovative and customised services to clients and their commitment to excellence and customer-centric approach has established them as a trusted partner in the industry. They are currently looking for a Quality Assurance Specialist to join their team.

Duties and Responsibilities:

* Responsible for the management of product safety, legality and quality as per relevant Quality Management System procedures

* Manage and maintain existing Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP) structures associated with Wholesale Distribution Authorisation (WDA) Licence.

* Develop, enhance and maintain the companies Quality Assurance Program, to meet the Best in Class standards.

* Maintain and develop ISO standards and establish key performance indicators.

* Identify and implement training to ensure proper and efficient completion of all quality functions using continuous improvement tools to instigate actions for improvements.

* Problem solve and present a detailed Root Cause Analysis to ensure timely completion of all corrective actions.

* Liaise with Business Development Personnel to ensure all customer accounts and communications are maintained and dealt with in a timely manner – audits, insurance documentation, customer questionnaires, HACCP, BRC and HPRA requirements.

* Attain and maintain Quality certifications as required in line with the Business direction.

* Be the representative for the company, and customer contact on all quality related queries, compliance requests, audits and follow up, customer complaints, quality agreements, and technical agreements.

* Manage the structure of all documents, systems, files and folders in a secure and consistent manner.

* Design, Structure and Implement a process to incorporate appraisals, audits, and approvals for all critical suppliers.

* Engage proactively with competent authorities and regulatory bodies in order to maintain legislative compliance.

* Promote the corporate quality culture within the company, promote awareness and reinforce understanding of quality processes and policies, facilitating compliance.

* Manage the Health and Safety, Environmental and Security Policy within the Quality System.

* Maintain compliance and report on temperature monitoring and engage with suppliers of quality related services.

* Renew as appropriate calibration and validation of all equipment, facilities and processes.

* Champion CAPA requirements of the organisation and proactively engage all stakeholders

* Promote customer focus within the business

Authority

• Promote customer focus within the business
• Promote product safety, legality and quality within the business.
• Place product on hold and in quarantine/ release product from hold and quarantine
• Notify regulatory bodies during a product recall or when falsified product identified
• Ensure processes required to retain certification of the Quality Management System are established, implemented and maintained.
• Approve areas/ product for safety following any large allergen spillage or glass breakage

Experience

• 5+ years of experience in a life sciences or similar environment with experience of GxP requirements – storage and distribution would be a distinct advantage.
• Strong understanding of quality systems, technical agreements and risk management. Experience with CAPA management, document control and change management.
• Proficient in MS office and experienced in eQMS platforms.
• Excellent communication and interpersonal skills with the ability to work in a busy team environment.