About The Company/role
This company is a well-known pharmaceutical company located close to Melbourne CBD.
They are seeking a Senior Specialist to join the Site Inspections and Compliance team.
8-month contract with potential to extend.
Monday – Friday, standard working hours.
Attractive Salary.
Duties
Reporting to the Senior Manager of QA Site Compliance, you will be responsible for aspects of Self Inspections and regulatory inspection preparation and management/execution activities and support preparation and coordination of Quality Management Review deliverables and KPIs. Your duties may include but are not limited to:
Providing support for the preparation and execution of Self-Inspection to verify compliance with global GMP regulations and corporate requirements.
The identification and assessment of risks and facilitating appropriate mitigations to ensure compliance and continuous improvement.
Participate and support Regulatory inspections at Seqirus site, including providing responses to regulatory authorities in a timely manner.
Maintain processes, procedures, and SOPs for auditing and inspections to improve audit readiness.
Working with global colleagues to support the harmonization, maintenance and application of global audit strategy, processes, and SOPs to improve consistency across the manufacturing sites.
Maintain and share knowledge of Regulations and Guidelines by staying up to date with industry and regulatory trends to ensure compliance and continuous improvement.
Participate in local Quality Management Review and KPI preparation.
About You
Bachelor's degree in a scientific discipline; Advanced degree is highly regarded.
Minimum of 3 years in quality or manufacturing experience in the biotechnology or pharmaceutical industry.
Experience as an auditor, both in internal and external audits.
Knowledge and experience in sterile product manufacturing, biological processes, and laboratory operations (preferred).
Knowledge of global cGMP regulations and ISO standards.
Excellent written and oral communication skills.
Demonstrate the ability to understand data sets and drive to data-based decisions.
Possess excellent analytical and problem-solving skills.
Be well organized and able to successfully manage deadlines.
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 Sarah or Cathy.
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