Senior QA Associate

About the company/role:

• Well-known pharmaceutical company
• Seeking Senior Specialist to join the Site Inspections and Compliance team
• 6-8 months casual contract
• Monday – Friday, standard working hours
• Must be flexible to travel between sites
• Open to Working Holiday Visas

Duties, but not limited to:

• Provide support for the preparation and execution of Self-Inspection to verify compliance with global GMP regulations and corporate requirements
• Identification and assessment of risks and facilitate appropriate mitigations to ensure compliance and continuous improvement
• Participate and support regulatory inspections at Seqirus, including providing responses to regulatory authorities in a timely manner
• Maintain processes, procedures, and SOPs for auditing and inspections to improve audit readiness
• Work with global colleagues to support the harmonization, maintenance and application of global audit strategy, processes, and SOPs
• Stay up to date with industry and regulatory trends to ensure compliance and continuous improvement
• Participate in local Quality Management Review and KPI preparation

Skills/experience:

• Tertiary education in a scientific discipline
• Previous quality/manufacturing experience in a similar role in the biotechnology or pharmaceutical industry
• Experience as an auditor 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
• Ability to understand data sets and drive data-based decisions
• 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 Linda on 03 9040 1630.


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.