Senior Quality Assurance Associate

About the company/role:
Well-known global pharmaceutical organisation
8 months casual contract
Monday – Friday, standard working hours
Flexibility to work from home.
Duties, but not limited to:
Maintain Quality Assurance System to ensure compliance with company and cGMP standards
Responsible for maintaining audit program, reviewing functional and release documentation and investigating deviations relevant to area of responsibility
Reviews lot release documentation and facilitates compliant release process for corresponding market
Responds to questions from authorities (TGA, FDA, etc.) to ensure timely product release
Ensures standard operating procedures (SOP's) stay current and align with corporate and regulatory requirements
Executes training/awareness related to GMP standards
Skills/experience:
Tertiary education in a scientific discipline
Previous quality/manufacturing experience in a similar role in the biotechnology or pharmaceutical industry
Knowledge of current Good Manufacturing Practices (cGMP) principles
Knowledge of TGA, FDA and EMA requirements
Batch release experience
Excellent written and oral communication skills
Excellent problem-solving skills and time management
Apply!
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 Priyanka on 03 9040 1630.

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