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Site QA Specialist

Reference ID : NHAA04
Category :
  • Pharma / Biotech
  • Medical Devices
  • Science
  • General Manufacturing
Date Posted : Nov 16, 2017
Job Location
  • Leinster
- Westmeath
Experience : 5+ Years
Salary : Neg
Employment Type
Nicola O'Sullivan
Contact Number : 087 0622429
QA Specialist required to oversee site activities within Midlands based pharmaceutical multinational

Principal Responsibilities

QA Specialist

An excellent opportunity for an experienced QA Specialist has arisen within a leading pharmaceutical multinational based in the midlands.  The successful candidate will have site QA responsibility providing technical expertise for all QA and compliance matters.

Key Responsibilities:

  • Act as quality point person, providing guidance and feedback on QA issues
  • Ensure relevant QA documents and procedures are approved to schedule to support Tech Transfers and New Product Introductions
  • Provide support for deviation investigations
  • Review and approve change control activities
  • Deliver QA review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports as required
  • Support review and approval of quality control documentation for the release of materials on site
  • Support inspection readiness activities.

Qualifications & Requirements

Education and Qualifications:

  • Third level qualification in a Science related discipline
  • A minimum of 3 years relevant experience within the pharma industry or a related field
  • Strong knowledge of cGMP requirements for pharmaceutical manufacturing
  • Experience of sterility assurance for drug products
  • Excellent accuracy and attention to detail
  • Technical Writing skills
  • Excellent interpersonal skills

For more information and a full job spec contact Nicola on 087 0622429 or forward your CV in the strictest confidence to jobs@headcount.ie

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