We need a full-time Consultant – Chemistry Technician to join our team based in Melbourne. As the largest employer of validation professionals in Australia, we offer you great development opportunities, training from world experts and the chance to work with the most prestigious companies locally, nationally and internationally.
The following attributes would be highly regarded:
* Consulting or leadership experience
* Experience in specialised GMP fields, such as aseptic or terminal sterilisation processes, non-sterile OSD manufacture, medicinal cannabis manufacture, cell therapies or technical transfer
* Computer systems validation and understanding of GAMP.
* Process validation and/or cleaning validation experience
* Ability to travel
Benefits and Responsibilities
* Operate, calibrate and maintain laboratory instruments and support new validation of laboratory systems following appropriate, current, regulatory and client requirements
* Support laboratory-based investigations and quality activities by conducting tests, documenting results to assist clients with quality, GxP and/or regulatory issues within the pharmaceutical and/or medical device or related industries
* Liaise with client to clarify testing requirements and support laboratory operations and understand their work practices and business
* Carry out laboratory tests and maintain GxP-compliant documentation to ensure quality, GxP and/or regulatory activities
* Work following current, relevant regulations, codes and guidelines regarding laboratory safety procedures, GxP requirements, chemical handling guidelines and analytical testing standards.
* Assist with the acquisition of materials such as laboratory chemicals, reagents, reference standards and consumables.
* Assist clients with change management activities such as laboratory methods, instruments and workflows to improve analytical processes and compliance.
* Perform other laboratory-related ad-hoc tasks such as sample preparation, equipment cleaning and routine analytical support activities that may be required by management from time to time
Qualifications & Experience
* A relevant science or engineering qualification – Tertiary qualification is desirable, however, any relevant qualification higher than Diploma is acceptable with prior relevant work experience
* At least 1 year of relevant work experience with a high level of exposure to and understanding of validation concepts, QA and/or manufacturing professional.
* Previous experience in a GMP manufacturing environment regulated by EMA, TGA, PIC/S or US FDA is preferred
* Demonstrable experience and proven knowledge and skills in GMP technical writing, e.g. SOPs and related QMS documentation, validation plans, protocols and reports.
About Company
PharmOut Pty Ltd is a leading international professional consultancy, specializing in servicing GMP industries. If you are looking for a career to challenge and excite you, PharmOut offers validation professionals varied and stimulating work across a diverse portfolio of clients.
Our core services include GMP compliance, validation, manufacturing design, architecture and engineering consulting to health sciences sectors including pharmaceutical, medical device, biologicals, medicinal cannabis, pharmacy and blood and tissue manufacturing industries.
Work Type: Full time
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