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Job Details

QA Documentation Specialist

Company: Thornshaw Recruitment
Reference: SM9205
Closing Date: 24 Nov 16
Type: Permanent
Salary (£): Negotiable

Job Summary:

Our client, a leading medical device company, is currently searching for an experienced QA Documentation Specialist. Candidates must have experience with the HPRA.


In this role, you will have responsibility for the following; 

  • Key member of the Operations Management Team and Corporate Quality Team.
  • ISO9001 Management representative (ISO9000,, ISO 9001, 5.5.2), ISO 13485.
  • Control of the Quality Manual including preparation, revision and execution.
  • Responsible for organising Management Review and compiling and reporting on the performance of the quality system.
  • Management of the product review and release system and signature on Certificates of Conformity.
  • Management of Change Control and Document Control Systems.
  • Issuing, control and filing of all batch related documentation.
  • Responsible for final sign-off on all product labels, package inserts and Marketing Material.
  • The organisation of product and facility inspection, preparation of procedures and instructions including certification assessment and surveillance audits, FDA inspections, other regulatory inspections and supplier audits.
  • Ensuring that validations are performed on equipment, processes and software used in manufacturing and testing of product.
  • The Management of non-conformance and corrective and preventative action systems including the control of further processing and delivery of non-conforming product until any deficiencies or unsatisfactory conditions have been corrected.
  • Responsible for coordination of issuing Product Safety Notifications or Product Recalls as well as Medical Device Reporting (MDR) with the Vice President of Regulatory Affairs.
  • Key participant in design control.
  • Assist with FDA regulatory submissions with the Vice President of Regulatory Affairs. 


This is a senior role with responsibility for all aspects of quality. We are searching for a high calibre candidate with the following background and experience:

  • Primary degree qualification in a science, engineering or business discipline or equivalent in terms of relevant operational experience
  • 5-7 years + industrial experience with preferably three years or more in the IVD industry.
  • Must have experience in project management of change programs
  • Firsthand experience of audits by regulatory authorities.  Ideally will have hosted and lead FDA and other regulatory authority audits.
  • Extensive experience of developing and delivering effective training on Quality Systems and Processes
  • Demonstrated track record and success in team building skills
  • Demonstrated experience of people management


For more information and to apply for this role please call Stephanie on +353 1 2784671 or e-mail 

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: +353 1 2784671

Apply for this job: QA Documentation Specialist

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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