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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Quality Consultant/Manager


Reference:SCANXU-174444 Location: Republic of Ireland
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Quality Auditor, Quality Control Manager, Quality Control Supervisor, Quality Manager, Quality Specialist

Quality Consultant/Manager-Fully remote working
Our client a pharmaceutical consulting organisation are currently recruiting for a Quality Consultant/Manager to join their team on a permanent basis. As Quality Consultant/Manager you will be responsible for providing key support to the Director/Senior Consultant in all matters relating to the provision of services to clients and customer base. This is 100% remote working.

Responsibilities

  • Liaise with customers with regard to their requirements, determining their needs and timelines and to manage client projects including the preparation of project proposals and the implementation of Project Plans including timelines and costings
  • Conduct Quality Audits for customers in line with auditing procedures and in line with all Pharmaceutical Regulatory requirements and Standards, to highlight deficiencies to the customers and to support (as required) in the remedy of those deficiencies
  • Advise and support companies in the establishment and improvement of their Quality Systems
  • Follow-up with existing customers to ensure satisfaction with service
  • Technical management of client projects ensuring the completeness of project plans, correct allocation & implementation of timelines and project costings
  • Prepare draft training material for external class-room based courses and for web based e-learning and downloadable training material
  • Co-deliver/deliver training to clients
  • Keep up to date with changing Regulatory Standards, Industry Best Practice and emerging trends to provide input to business development and product development opportunities
  • Follow-up with existing clients and potential new clients to increase client base and increase sales
  • Prepare draft company publications including the Regulatory Update Bulletin and e-Newsletter, liaising with Associates, Industry personnel/sources to gain input and ideas for content
  • Deal with internal/external customer contacts and resolve queries and problems in an effective manner and timely manner
  • Liaise with Clients, regulatory authorities and other external parties as required / requested on behalf of clients
  • Ensure compliance with the organisations company policies and procedures, including Quality Systems, and E, H&S requirements
  • Ensure all documentation prepared is in line with standards as set down by relevant Legal and Regulatory bodies

Requirements
  • 3rd Level Qualification in Science or Quality Management
  • In excess of 15 years’ experience in GMP in sterile and biotech drug products.
  • 15 yrs experience in Quality Assurance or Quality Compliance role.
  • High level Computer Literacy and competency – Microsoft Office, Microsoft Project.
  • Vendor Auditing Experience
  • In-depth understanding of regulatory requirements applicable to the Pharmaceutical Industry, and knowledge of the sources of regulatory information (medical devices and cosmetics industries also considered).
  • In-depth understanding of the purpose, objectives and scope of Quality Systems
  • Effectively resolving compliance issues
  • Experienced in working with third parties
  • Creation of third party contracts / project agreements
  • Experiened orking in cross-functional teams
  • Contributing to company programmes or projects
  • Managing change, influencing stakeholders and delivering results
  • Strong Communication Skills – strong business English capability
  • Strong technical writing skills
  • Project Management Skills
  • Strong Interpersonal Skills
For more information please contact Sinéad Cullen on +353879500821 or [email protected]