Validation Engineer

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Our Sun Pharma Port Fairy Site is seeking a suitably skilled and experienced person in our Quality Assurance team in the role of Validation Engineer.

Summary about this job

Quality Assurance & Control

Company: Sun Pharmaceuticals Pty Ltd

Location: South West Coast VIC

Work type: Full Time

Salary: n\a

Phone: +61-2-3888-9389

Fax: +61-8-4971-1352

E-mail: n\a

Site:

Detail information about job Validation Engineer. Terms and conditions vacancy

Based at Port Fairy, Victoria

 

Sun Pharmaceuticals is a stand-alone operation which accounts for >25% of the opiate supply into the global pharmaceutical industry, with leadership in market share, quality, reliability, and customer partnership. It encompasses agricultural operations, manufacturing across two sites, third-party sales to global customers, and associated multi-tier R&D operations. 

We are now seeking a suitably experienced candidate to join the Quality Assurance team at our Port Fairy site.

This role will be responsible for:

  • Ensuring own safety and that of colleagues.

  • Responsible for management of existing validation systems across the Port Fairy site to ensure robust and compliant manufacture of registered products to ensure that only safe, compliant product is released to market. 

  • Managing site change control and validation activities to meet above-site quality performance targets / KPIs (+ metric collation).
  • Ensuring that effective validation and change control processes, practices and systems are maintained to be “in place” and “in use”.
  • Responsible for ensuring that site facility, plant, process, cleaning & computerised system validation activities are completed to required timelines and are maintained in a ‘validated state’.
  • Being an active member of the quality team.

Qualifications and Experience:

  • Previous experience (5 years+) in a similar quality role. It is preferable, but not essential, that some of this experience was in a Validation Engineer role in a Chemical, Pharmaceutical or related industry.

  • Undergraduate Degree in Engineering or related discipline 

  • Ability to demonstrate functional understanding of TGA Code of GMP

  • Sound understanding of quality systems as relating to manufacturing or pharmaceuticals.
  • Demonstrated ability to analyse data sets.
  • Demonstrated ability to use statistical packages (Excel or other software)
  • Ability to communicate clearly and concisely, verbally and in writing.

Shortlisted candidates will be required to undergo a Criminal History Background/Police Check as a mandatory part of the recruitment process.

An attractive TRP will be offered to the successful candidate.  

If you believe you meet the criteria above please forward your resume by pressing the "Apply Button" now.

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