Connecting...

QA Specialist

Job description

QUALITY SPECIALIST

 

This job will primarily be involved in supporting and coordinating day to day activities including Batch Record Review, SOP, Change Control, Deviation and CAPA management of Third Party Manufacturers.

 

Job Responsibilities:

 

  • Responsible for day to day activities designed to maintain and enhance the local Quality Management System

  • Support the continuous improvement of the QMS including the development and implementation of improved quality reporting measures

  • Effective management and coordination of Quality Management Systems including change control, Deviations, CAPA, SOP’s

  • Responsible for the writing, training and management of SOPs including associated training requirements

  • Maintenance of system to ensure appropriate review and completion of Annual Product Quality Reviews

  • Support or where necessary lead Quality based projects including working as part of a multidisciplinary team as required

  • Coordinating quality related customer complaints

  • Provide direct support during competent authority audits

  • Assist in conducting internal self-inspections and external audits as appropriate

  • Review and co-ordination of batch records and associated documentation 

  • Job Requirements:

  • Bachelor’s Degree required.  Chemistry or Life Science degree preferred

  • Minimum of 3-5 years’ experience in QA/Compliance in pharmaceuticals or related industry.

  • Prior pharmaceutical or quality assurance experience essential

  • Strong analytical skills and knowledge of quality system essential

  • Ability to manage virtual organisations and report effectively to internal management

  • Experience with CMOs an advantage

If you would like to apply to this job please contact Clara on 01 4744676 or email chenry@sigmar.ie