Sterility Assurance Specialist

Pharma Manufacturing | GMP & sterility validation | Permanent role | Government lab, TGA/ Pic/s Annex 1 | Career progression 

• Leading government organisation – pharmaceuticals/TGA/Annex 1
• Previous experience in a senior level sterility validation role required
• End to end contamination control experience

About the company:

The company is a well-established government body in the field of nuclear science and medicine based in South Sydney. Rare opportunity to join the team in a permanent capacity.

About the Role:

Evolve Scientific is seeking an experienced Sterility Assurance Specialist for our clients sterile manufacturing facility. Experience and a proven track record in sterile contamination control validation. Drive projects to design and implement a new contamination control strategy (CCS) alongside senior management and executive level stakeholders.
This organisation adheres to strict external regulatory requirements including TGA, FDA. The role will oversee transition to the revised PIC/s Code to GMP, Annex 1 through implementation of an end to end contamination control strategy, for the manufacture of sterile medical products.

Duties:

• Subject matter expert for sterility assurance function
• Lead investigations, risk assessments and CI initiatives relating to sterility CCS
• Design and validate equipment across the whole manufacturing facility to meet the PIC/s guidelines
• Monitor and report on sterility assurance metrics and trends and initiate complex investigations into deviations and CAPAs
• Lead sterility assurance education programs across the Nuclear Medicine business
• Oversee transition to revised PIC/s Code to GMP Annex 1

Skills & experience:

• Tertiary qualifications in science or engineering essential
• Experience in a sterile/GMP pharmaceutical manufacturing facility
• Experience in contamination control and it’s design and implementation
• Strong knowledge in TGA/PIC/s and other relevant regulatory bodies
• Excellent interpersonal and communication skills

Benefits/Culture:

• Band 6 - $107-124K + 15.4% salary
• Parking, childcare, gym, swimming pool, café on site.
• Permanent government role
• Training, development and mentoring opportunities
• Performance based salary increases
• Work-life balance with generous leave entitlements and flexible conditions

As a requirement, you must hold PR/Australian Citizenship to apply for the role as this is within a Government department. PR may be considered.
Applicants will need to complete a pre-employment medical and security clearance.   

How to 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 Susan on susan.macleod@evolvescientific.com.au

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