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QA Specialist New Product Introduction

Job Title: QA Specialist New Product Introduction
Contract Type: Permanent
Location: Dublin
Industry:
REF: 122562
Contact Name: Laurentina Kennedy
Contact Email: laurentina@rftgroup.ie
Job Published: 11 months ago

Job Description

Quality Specialist fast growing young pharma Permanent 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
o Management of deviations, CAPA?s and change control notifications associated with commercial products.
o Preparation of batch documentation for approval
o Operation and maintenance of quality documentation system
o 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
Scientific or technical qualification (Minimum NFQ level 8)

For further information on this Quality Specialist role please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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