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Quality Assurance Officer R&D

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Science
  • Date posted: 14/07/2017
  • Job reference: J362564A
This vacancy has now expired.

Quality Assurance Officer R&D

Job description:

The role of R&D Quality Assurance Officer is to support the R&D Quality Assurance Team. The new R&D Manufacturing facility will include sterile and non-sterile manufacturing. As a result Quality Assurance support for new equipment qualification, vendor qualification and new product development from conception through to commercialization will be required.

Responsibilities:

  • To support the Head of Quality and the R&D Quality Assurance Team Lead with the quality assurance function.
  • Support R&D with QA support in batch documentation review and assessment of manufacturing events.
  • Electronic Documentation Management System - QUMAS, Involving checks prior to 'QA Authorisation'.
  • Review and approval of Regulatory deficiency responses.
  • To ensure that all work carried out in onsite is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • Attend Product review meetings and provide support on the development of new Products
  • Liaise with regulatory affairs/ formulations / laboratory personnel to ensure regulatory and quality requirements are met.
  • Assist with review of Submission Documentation in support of license applications and customer requirements.
  • Noncompliance reporting and corrective action / continuous improvement implementation.
  • Operation of SAP (ERP System) Quality function as per procedures.
  • Support the on-going OOS/IR/CACI closeout programme.
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • To support on-going projects by carrying out Vendor and URS reviews and approval.
  • Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs

Qualifications & Experience:

  • BSc (Require Quality Management as a part of degree)
  • Minimum of 2 - 4 years QA experience in a GMP compliant role
  • Experience with desktop and internet-based software applications (e.g. electronic document management system, MRP system) an advantage but not essential.
  • Excellent communication and presentation skills
  • Focus on quality and detail
  • Careful planning to achieve accurate and timely results
  • Ability to define and manage own tasks and schedules
  • Experience performing and assessing risk/impact assessment an advantage
  • Sterile manufacturing experiences would be of benefit
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