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QUALITY ENGINEER

 

Company:

HARMONICS RECRUITMENT & SEARCH
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Job Reference Number

14566158

Client ID:

RI/5526
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Posted On:

Feb 6 2012

Location:

GALWAY, CLARE
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Job Type:

Contract

Salary:

45,000 - 55,000
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Our Galway based Client has a requirement for a Quality Engineer for an initial 12 month contract. This role may suit an individual with good start up experience ideally from a pharma/biotech background.

KEY RESPONSIBILITIES

  • Responsible for ensuring Quality systems and associated site procedures are continuously updated and maintained in compliance with current EU Regulations for the manufacture of investigational medicinal products.
  • Play a leading role on cross functional teams involved in the development, manufacture, review and approval of investigational medicinal product batches and other similar projects e.g. tech transfer, scale up etc.
  • Play a leading role in identifying requirements of product/process investigations and enhancing the reporting systems in place.
  • Provide leadership for deviations, complaints and any other related quality systems ensuring appropriate root cause analysis has been employed.
  • Liaise with personnel involved in projects, monitoring, and other QA activities as required.
  • Ensure timely and appropriate review and approval of Validation documentation both process and/or equipment.
  • Play appropriate role in the development, operation and evaluation of continuous improvement training/retraining programmes.
  • Ensure standards are maintained within the requirements of GMP.
  • Responsible for particular projects e.g. product launches, improvement projects.
  • Set up and review Quality Assurance Technical Agreements with the Trial Sponsor, Contract laboratories, Service providers etc.
  • Carry out audits ofGMPfacilities involved in the manufacturing of medicinal products used in the clinical study.
  • Set up and maintain Product Specification Files (PSF) for the medicinal products to be released for a clinical study.
  • Review and approve medicinal products documentation for the product to be used in a clinical study.
  • Ensure continuous development and improvement of the Standard Operating Procedures related to the QP release process.


REQUIREMENTS

  • Minimum 5- 8 years’ experience within Biotechnology/Pharma industry.
  • Degree in Science, Quality, with particular focus on Biotechnology or a related discipline would be an advantage.
  • Be familiar with and maintain Product Specification Files (PSF) for the medicinal products to be released for a clinical study.
  • Excellent Knowledge of EUGMP Regulations, including the requirements for investigational Medicinal Products, and clinical trial legislation - directive 2001/20/EC,
  • Knowledge of validation, regulatory affairs, equipment, services, etc. associated with manufacture of finished pharmaceutical products and Investigational Medicinal Products.