Quality Specialist

Job Title: Quality Specialist
Contract Type: Permanent
Contact Name: Gerry Kennedy
Contact Email: gerry@rftgroup.ie
Job Published: about 6 years ago

Job Description

Quality Specialist     fast growing young pharma                    Dublin

  • Are you looking to join a young, fast growing, highly ambitious young pharmaceutical company ?
  • Rapid growth in a small business requires individuals who possess a natural ‘can do ‘mentality, who will deal effectively with new challenges and where no two days are the same !

The Company is a growth oriented, investment backed organization, with management and staff taking a “can-do” approach to all day to day activities and projects. Tasked with data collection, management and analysis, you will have a “hands-on” approach, strong attention to detail, judgement and decision making, planning and organising skills, as well as the ability to communicate effectively both verbal and written.

Job Spec:

  • Development, implementation and maintenance of the Quality Management System
  • Management of deviations, CAPA’s and change control notifications associated with commercial products.
  • Preparation of batch documentation for approval
  • Operation and maintenance of quality documentation system
  • Preparation and delivery of training on QMS, SOP’s and processes.
  • Developing and reporting quality metrics
  • Participating in periodic review of the QMS and management review.
  • Preparation of annual reports, annual product reviews and core documents.
  • Internal quality review
  • Management of Supplier Evaluation and Approval
  • Support  Artwork Changes
  • Preparation for  and involvement in Regulatory Inspections
  • Vendor evaluation and auditing of CMOs and SSPs
  • Preparation of Regulatory filings
  • Pharmacovigilance
  • Customer Complaint Investigations

Person Spec:

  • Comfortable working in a small team, operating with a wide scope
  • Dynamic environment, rapidly growing company
  • Some travel expected
  • Willing to learn on the job
  • degree qualified 

Cv to gerry@rftgroup.ie   01 2302400   www.rftgroup.ie