AddressThe Laboratories Branch is responsible for post market monitoring and compliance testing, investigations and reviews, as well as market authorisation assessment for medicinal goods.
The branch conducts laboratory testing in accordance with the laboratories testing program; provides scientific expertise to assess technical data for marketing authorisations; provides scientific and expert advice to internal and external stakeholders including industry, government and international agencies, and participates in the development of standards and international collaborative activities.
The division undertakes physical and chemical testing of medicines in response to external complaints or alerts raised by regulatory areas within the division. Targeted testing surveys of medicines are also conducted, as is the investigative testing of unregistered therapeutic goods to support enforcement and compliance activities.
Key Duties- Conduct, analyse and report on testing of goods to verify that they meet the required quality standards, to support investigations conducted in response to public health and safety concerns and for the purposes of accreditation, standardisation and international harmonisation
- Draft laboratory reports documenting the results of testing for approval by testing or project managers
- Assist in the development of planned testing projects through undertaking literature searches, selecting products for testing, and drafting product requests
- Participate in the development of new testing methods and the establishment of their reliability and validity
- Prepare and maintain laboratory records of testing in line with quality system and accreditation requirements and record data in the information management system, ensuring the highest standards of accuracy and clarity
- Contribute to the development of high quality, evidence‐based testing manuals and SOPs
- Maintain current knowledge of new testing methods and tools and train and guide new staff to develop their familiarity with testing methods and equipment used in the laboratory
- Exchange information with other work areas across and outside the HPRG including negotiating time frames for work completion
Our ideal CandidateThe ideal candidate will have -
- An understanding of chemistry and associated analytic techniques and testing protocols
- A capacity to undertake data analysis of data and an understanding of statistical methods
- An understanding of and capacity to work within a laboratory quality management system
- A strong capacity to pay attention to detail and to produce accurate, high quality work
- Strong communication skills including the ability to produce high quality written reports
- The ability to build and sustain positive working relationships with team members
- Experience working in a laboratory
Qualifications
Candidates must have a science degree with preference for chemistry and related fields
Sounds like you -
If you believe you have the right qualifications and skills for the role and are interested in the role, please click apply or email your updated CV to ***************@randstad.com.auAlternatively, please contact Ashwinder Singh from Randstad on 02 6132 3*** for a confidential discussion.
At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.
