QA Documentation Specialist

Contract
Cork, Ireland
Posted 9 months ago

The Documentation Specialist will provide compliant, accurate and timely documentation support to the Quality team.

 

Responsibilities

 

  • The Documentation Specialist is accountable for the smooth execution of all appropriate documentation associated within QA.
  • They will contribute to the High Performance culture within the Quality Team by providing a flexible, accurate service to enable them to achieve key priorities.
  • The Documentation Specialist is an active member of the cross functional QA Team, providing support, guidance and expertise to ensure the success of the Quality Department.
  • Will participate and comply with the site Quality Management System (QMS) requirements, including ownership, as relevant to you.
  • Updating of procedural documents
  • Preparation of change control documentation
  • Processing of documentation through the Change Control System
  • Review of batch records and recording of incidences of corrections made to batch records
  • Generation and control of protocols.
  • Responsible for supporting a culture of Continuous Improvement by deploying site Six Sigma tools within Quality.
  • Coaching others by sharing their skill-set and expertise.

 

 

Qualifications & Education

 

  • Demonstrated knowledge of the requirements for entries and completion of batch records.
  • Knowledge and experience of GMP and GDP in a pharmaceutical environment.
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Manufacturing, Quality, Engineering, Tech Services etc).
  • Experience in the Pharmaceutical industry or a similar operating environment.
  • Knowledge of and experience in applying Lean Six Sigma and Lean methodologies.
  • Minimum Leaving Certificate with a requirement to advance to a relevant 3rd Level Qualification (Science, Engineering, Quality, Production) within a three year period.
  • Desirable: Qualification in a biological science subject.
  • Desirable: Evidence of Continuous Personal Development.
  • Desirable: Six Sigma Yellow Belt.
  • High level technical writing skills

 

 

To apply contact Martin Lynch on 087-344 3581.

 

Email CVs to mlynch@mile.ie

Job Features

Job CategoryQA

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