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  • Job reference: RMS0216320

QRA Specialist

  • Sector: Other
  • Location: Thailand
  • Job type: Permanent
  • Date posted: 09/09/2019
  • Duration: 1 month
This vacancy has now been filled.

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The Role:
* To lead and support quality assurance and regulatory affairs activities in accordance to local regulation and Corporate SOPs in Thailand
* Partner and provide guidance to all internal team members and external stakeholders on QARA related matters
* Implement and maintain ISO QMS in Thailand, including coordinate annual inspection audit and management review activities
* Report Adverse Event according to Thai FDA regulation and Global SOP
* Coordinate and execute Field Safety Corrective Action per local regulation and Global SOP
* Manage product registration activities, ensure product licenses are renewed on time to minimize business impact
* Provide registration requirements for new projects / products development as well as product change
* Build professional relationship with local regulatory authorities
* Provide guidance and solutions to other departments on all matters relating to quality including regulatory compliance, including monthly status update

Essential Skills / Qualifications:
Degree in Science or Chemist.
At least 7 years of experience in quality management system.
Excellent communication, presentation, co-ordination and inter-personal skills.
Good command over spoken and written English and proficiency in computer.

About Fircroft:
Fircroft has been placing people in specialist technical industries for approaching half a century, focusing on mid to senior level engineers for contract and permanent roles worldwide. By applying for this job you give consent for Fircroft to contact you, via email & telephone, to discuss your application along with future positions and Fircroft's services.

Fircroft is registered as a Data Controller with the Information Commissioner as required under the General Data Protection Regulation 2016/679. Fircroft will only process your personal data for the specific purposes of managing your application.

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