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
With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide. With more than 80 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.
Submission Form
Submit your message along with your CV attached, and one of our specialists will be in touch.