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Job Reference Number


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Posted On:

Mar 6 2012



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• Produce and maintain appropriate and comprehensive quality process specifications as required during the development and implementation of new products. Quality process specifications to be compiled for on site production and purchased for resale goods.
• Document and maintain in good order all relevant Quality assurance sections of Product Development History File and DMR as directed by Data Management.
• Compile and execute validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material.
• Provide QA input for URS for new technology / equipment.
• Co-ordinate product/technology transfer between facilities from a QA perspective. Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.
• Liaise with R & D to ensure CTQs are agreed and documented for all NPD.
• Lead Design for Inspection activities for all NPD to ensure latest technology is available to reduce Human factor.
• Lead QA input in Design for Manufacture activities on site.
• Ensure correct use of statistical QA methods into the production environment, and provide technical resource for production team on relevant IQ/OQ/PQ protocol issues.
• Ensure compliance with all Documented Quality system, as per SEP 180 i.e. FDA QSR’s and ISO 13485/9001 requirements etc. during day to day and assigned audit/CAPA activities
• Provide technical assistance to carry out problem analysis/complaint investigation as required and define through negotiation effective corrective actions.
• Assist in problem solving in established production process enabling reduction in scrap and reprocessing.
• Review and approve product, gauge, tooling and fixturing drawings.


  • Degree level qualification in Science/Engineering or Equivalent.
  • Minimum 5 years experience in a quality role within Pharmaceutical/Medical Device Industry.
  • Proven ability to successfully introduce new product development in the Medical Device/Pharmaceutical Industry.
  • Proven knowledge and ability regarding product verification and process validations including software and automation experience.
  • Proven knowledge of FDA and MDD GMP requirements regarding medical Devices and Pharma.
If this position is of interest, please forward your CV to Fastnet Recruitment [email protected]

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