Improvements And Compliance Project Leader - Quality Control -

Job scope

• Job Type:Permanent
• Salary:$80000 - $90000 per annum + super
• Location:Melbourne
• Reference:RE-12502785 
• Contact Telephone:+61 2 82 51 1100

Recognised and respected as one of the world leaders in vaccine manufacturing, this top 10 global pharmaceutical company is currently seeking an experienced Improvements and Compliance Project Lead to join their Quality Control Department and assist with their growing project load

Known for providing innovative and class leading products which enhance the health and wellbeing of customers throughout the world, this leading Pharmaceutical company based in Melbourne is in need of an experienced Improvement and Compliance Project Lead to step in to the QC department and provide leadership and guidance for a variety of validation and qualification projects in their laboratories. This is a challenging but highly rewarding opportunity to work with the largest pharmaceutical company operating in Australia.

Reporting to the QC Improvements and Compliance Manager, your main responsibilities will include:

* Supervising and effectively directing staff members to ensure the timely implementation of assay validation projects and that all Quality Control requirements are met

* Advise management on the implementation of new technology options to improve cost efficiency and compliance status

* Liase closely with other departments to identify and evaluate the need of any new QC testing methods

* Keep up to date with current assay developments

* Lead and coordinate development teams (including coordination and participation in assay assessment testing)

* Ensure that all project work is completed according to GLP and cGMP standards

* Develop and maintain an effective project monitoring system (monitor maintenance materials and labour records)

* Develop and implement a functional LIMS system in accordance with QC department needs

* Facilitate the training and development of staff

* Ensure all operational performance fits with the organisations Quality Management System

For you to be the successful applicant in this position, you must have:

* Tertiary qualifications in Science or the equivalent

* Experience with immunochemistry or immunology will be very highly regarded

* Have a thorough understanding of the ICH & EMEA guidelines

* Have experience working within a GLP and cGMP environment

* Experience with CFR part 11 will be highly regarded as well

* Have a good understanding of drug manufacturing processes

* Be familiar with LIMS

* Have proven experience leading and providing direction to other employees

* Project management experience

* Have excellent problem-solving skills and be able to provide innovative solutions in a timely fashion

* Excellent written and communication skills

This is an excellent opportunity to develop your management experience and build your career in one of the world's most innovative organisations. If you feel you meet the criteria for this role, do not hesitate to apply via the link provided. If you would like any additional information, please contact Daniel Briggs on (02) 8251 1100.

To find out more about Real please visit www.realstaffing.com