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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