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Pharma/Biomedical - Technical Writer

Pharma/Biomedical - Technical Writer

Job Title: Pharma/Biomedical - Technical Writer
Contract Type: Contract
Location: Australia, Melbourne
Industry: Manufacturing
Reference: 3429139
Contact Name: Chris McCutcheon
Contact Email:
Job Published: April 20, 2022

Job Description

Pharmaceutical/Bio Medical - Technical Writer – Change Controls

Location: Eastern Suburbs of Melbourne
Duration: 12 Months (Possible extension)
Start: ASAP

This is an excellent opportunity for an experienced Technical Writer to join a world leading pharmaceutical, working on a highly interesting project. As part of the Operational Readiness team, you will support with the generation of technical documentation writing/editing.

You will work on documents, such as technical procedure manuals, user manuals, programming manuals, service manuals, operational specifications and related technical publications to communicate technical specifications and instructions clearly and effectively to a wide range of audiences. 
Main responsibilities:
This position is responsible for the coordination and oversight of the following functions within the Capital Projects department:
  • Manage and facilitate the Change Control process within Capital Projects, ensuring that all records are closed on time or where an extension due, an interim report is submitted ahead of time.
  • The review and update of GMP related documentation.
  • Contribute to completion of project milestones and organize own work to meet project task deadlines. 
  • Support the Production teams with update to or creation of master supporting and master controlling documentation and the associated change controls.  
  • Assist with the management of scheduled periodic review of production documentation, as well as the update of documentation to align with company policy practices and standards. 
  • Participates in updates of documentation to ensure documentation is maintained and current for the Functional unit. 
  • Participates in risk assessment investigations within the Functional Unit. 
  • Participates in the review of Key Performance Indicators (KPIs) and assist in the development of future performance targets. 
The successful candidate will have;
  • A tertiary qualification in Science, Training or equivalent experience.
  • Experience in the Pharmaceutical (or a highly regulated) industry
  • Experience executing Change Controls. (preferred)
  • Experience in a project environment (preferred)
  • Knowledge of cGMP / training requirements.
  • Technical / Professional knowledge - keeping abreast of current trends and developments in GMP Documentation
  • Writing and verbal communication skills (especially technical writing).
  • Willing to actively draw on and act on information contributed by team members.
  • Computer skills in MS Word, MS Excel, MS Powerpoint and MS Outlook.
Benefits of this role;
  • Work with a world class business on high profile projects.
  • Excellent long-term opportunity.
  • Work within a highly skilled team.
  • Excellent remuneration.
Design & Build specializes in recruitment for the Construction, Manufacturing, Engineering & Property industries on a national basis. Design & Build prides itself on only hiring recruitment specialists, finding the right people for the right jobs and doing the right thing by both job seekers and employers alike.
For any questions relating to this role please contact Chris on 0412 747 198 / or click apply. Your application will be treated as strictly confidential.

Thanks for your consideration.

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