**********Must have experience working in Storage and Distribution – Quality***************
5+ years of experience in a
Storage and Distribution,
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
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 agreement
* 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.
* 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