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Quality Specialist

Job Title: Quality Specialist
Contract Type: Permanent
Location: Dublin
Industry:
Salary: 40
REF: 122566
Job Published: over 2 years ago

Job Description


Title: Quality Specialist
Location: Location: Dublin, Ireland

Job Specifications:

Responsibilities may include, but are not limited to:

  • Development, implementation and maintenance of our clients Quality Management System
  • Management of deviations, CAPA?s and change control notifications associated with our client?s 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 Specification:
  • 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)
Key Competencies
  • Good communication skills ? verbal and written
  • Data collection, management and analysis
  • Planning and organizing
  • Judgement and decision making
  • Attention to detail

It is not intended that this is an exhaustive list of responsibilities but rather a representation.
Contact Gavin (01) 2302400 or Email gavin@rftgroup.ie