About the Company:

Proclinical are proud to be partnered with our client, a global Biopharmaceutical leader renowned for its innovation and commitment to delivering medicines to treat health conditions and improve quality of life. At their Parkville site, they manufacture vaccines including influenza and Q fever vaccine as well as Products of National Significance such as Antivenoms.

About the Role:

As part of the Quality Assurance Batch Release team, reporting to the Senior Associate, the 2 x Quality Assurance Associate is responsible for the quality assurance and compliance activities including the review of GMP documentation for IVV manufacturing in accordance with applicable regulatory requirements;

Start: ASAP
End: Till end of September
Hours: Standard Mon to Fri flexible on start time (ie between 7am and 9:30am start)
Pay rate: $45.75 - $50.75 p/h + superannuation
Vacancies: x 2

Responsibilities:

• GMP document reviews in IVV Manufacturing including the independent management of work and finalising documents to give to senior associate
• Reviewing batch manufacturing documentation according to schedule to ensure the batch documentation meets the required quality standards, registered specifications and the approved manufacturing process.
• Provide Quality support and work closely with key internal stakeholders including Manufacturing, Quality Control and QA colleagues
• Utilise business systems including the electronic Quality Management System (eQMS), Laboratory Information Management System (LIMS), Enterprise Resource Planning (ERP) system, and Document Management System.
• Follow Standard Operating Procedures (SOPs) and maintain compliance to current Good Manufacturing Practice (cGMP) regulatory guidelines

Skills and Experience Required:

• University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
• 3+ years' GMP experience in pharmaceutical/biotech or other regulated industry
• Knowledge of current Good Manufacturing Practices (cGMP) principles
• Knowledge of TGA, FDA and EMA requirements
• Production experience
• Batch release experience

How to Apply

If you are interested and would like to apply for the position, please click the apply button and upload an up to date resume and optional coversheet highlighting your experience per the requirements of the role. For further information, please contact Pamela on 02 9054 7411 or email [email protected]

About Proclinical

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.