Senior Quality Assurance Specialist

3 weeks ago

Parkville, Victoria, Australia Evolve Scientific Full time

About the role:

  • Join a well-established global pharmaceutical organization as a Senior Quality Assurance Associate.
  • Work on a casual contract basis for 8 months, Monday to Friday, with standard working hours.
  • Enjoy flexibility to work from home.

Key responsibilities:

  • Maintain a Quality Assurance System to ensure compliance with company and cGMP standards.
  • Develop and implement an audit program, reviewing functional and release documentation, and investigating deviations relevant to the area of responsibility.
  • Review lot release documentation and facilitate a compliant release process for corresponding markets.
  • Respond to questions from regulatory authorities (TGA, FDA, etc.) to ensure timely product release.
  • Ensure standard operating procedures (SOPs) remain current and align with corporate and regulatory requirements.
  • Deliver training and awareness programs related to GMP standards.

Requirements:

  • 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 now:

Send a cover letter and a detailed resume in WORD format (PDFs can be corrupted/not processed). If you have any questions, please contact Priyanka on 03 9040 1630.

NES Fircroft (NES) is a leading engineering staffing provider with over 90 years' combined experience. We offer contractors a range of benefits, including visa and work permit support, market-leading benefits packages, and accommodation. Our clients include major companies in the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining, and Manufacturing sectors.

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