Quality Assurance Manager - Operations

Operational senior leader I TGA Pharmaceutical Manufacturing | Government, permanent | Aust Citizens only | TGA, GMP | Hybrid WFH
 
Band 7 classification - $124-139K + 15.4% super - negotiable.
Nuclear medicine, radio pharmaceuticals - TGA/GMP
Manage product release quality functions, Australian citizenship essential
 
About the company:
 
Evolve Scientific is partnering with ANSTO, a well-established leader in the field of specialised nuclear science, technology, environmental and pharmaceutical research and is recognised worldwide. The company is based in the southern suburbs of Sydney.
 
This government organisation is focused on undertaking leading edge research, delivering innovative scientific services and providing specialised advice to government, industry, academia and other research organisations.
 
About the role:
 
Evolve Scientific Recruitment is seeking a Quality Assurance Manager – Operations, to lead and direct the QA team, manage overall authorisation of release for supply and second stage release of finished goods and API.
This role guides all aspects of quality, deviations and product release along with the overall operational effectiveness of the section.
 
This role would be ideal for an experienced 2IC or Quality Manager, with a breadth of experience across all aspects of pharmaceutical manufacturing, looking for the opportunity to break into one of Australia’s leading government organisations.
 
Reporting to the HOQ the role will entail managing quality related functions, including:

• Leading and developing staff to ensure a depth of technical knowledge within Nuclear Medicine.
• Conduct regular evaluation of quality product systems including analysis of changes in legislation, nuclear medicine policies, procedures, training, and communication.
• Manage overall release for supply and second stage release of starting material, intermediates, finished goods and API in accordance maintaining current regulations whilst meeting operational and customer requirements.
• Consistent compliance to TGA, GMP and ARPANSA regulations with compliance and validation activities.

• Tertiary qualification in science, engineering or related
• Experience in leading, managing and mentoring a team and the performance of staff; in a manufacturing environment.
• Knowledge of Codes of GMP, TGA, ISO 9001/14644 or similar eg APVMA in sterile manufacturing
• Well versed in guidelines, compliance requirements.
• Demonstrated experience in the application of Quality Risk Management to pharmaceutical processes including understanding of compliance and risk management frameworks.
• Excellent organisational, interpersonal, communication and presentation skills.
• Excellent problem solving skills and flexibility in responsing to changing demands; ability to meet critical deadlines whilst maintaining accuracy and attention to detail.

• This is a permanent position that can offer flexibility and options for partly WFH/hybrid
• Band 7 classification - $124-138K+super - negotiable.
• As a requirement, you must hold Australian Citizenship to apply for the role as this is within a Government department.
• Applicants will need to complete a pre-employment medical and 8 week security clearance.
• Public transport to the company is limited but plenty of parking is available.
• Pool and leisure facilities on site
• Mon-Fri

If you think this could be the role for you then please apply now! Please send us a cover letter AND a detailed resume in WORD format (PDFs can be corrupted / not processed).  
Or, if you have any questions, please contact Susan on *************@evolvescientific.com.au
 

With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide. With more than 80 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.