Permanent GMP Validation Specialist – Sterile QA

Evolve Scientific; Melbourne; On-site; AUD 90,000 - 120,000; Full time

Job summary

Evolve Scientific seeks a qualified professional to plan and execute qualification activities in a GMP-regulated environment. You will develop, review and approve validation documentation for facilities, equipment and processes, including IQ/OQ/PQ, while supporting audits and continuous improvement.

Based in Melbourne's southeast suburbs, this full-time role requires a minimum of 3 years in pharma manufacturing, with strong sterile processing experience and excellent communication skills.

Qualifications

• Bachelors degree or higher in a relevant science/engineering field.
• Minimum 3 years' GMP-regulated pharmaceutical manufacturing experience.
• Strong understanding of sterile processing and pharmaceutical manufacturing.
• Demonstrated problem solving, decision-making and teamwork.

Responsibilities

• Plan, coordinate, execute, review and approve qualification activities.
• Develop and approve qualification documentation including protocols and reports.
• Perform IQ/OQ/PQ for facilities, utilities, equipment and computerized systems.
• Manage quality system processes including deviations, investigations, CAPAs and change control.
• Support development and maintenance of QC/validation procedures.
• Assist internal and customer audits and regulatory inspections.
• Promote quality culture and continuous improvement.

Skills

Sterile processing

Quality systems

Problem solving

Communication skills

Education

Bachelor's degree in Science/Engineering/Pharmaceutical Science

Job description

Evolve Scientific seeks a qualified professional to plan and execute qualification activities in a GMP-regulated environment. You will develop, review and approve validation documentation for facilities, equipment and processes, including IQ/OQ/PQ, while supporting audits and continuous improvement.

Based in Melbourne's southeast suburbs, this full-time role requires a minimum of 3 years in pharma manufacturing, with strong sterile processing experience and excellent communication skills.