Quality Validation Associate

Evolve Scientific; Melbourne; Presencial; AUD 90.000 - 120.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Sterile processing

Quality systems

Problem solving

Communication skills

Educación

Bachelor's degree in Science/Engineering/Pharmaceutical Science

Descripción del empleo

bout the role:

• Pharmaceutical company


• Based in the Southeast suburbs of Melbourne


• Permanent Opportunity


• Monday to Friday, full time hours

About your duties:

• Plan, coordinate, execute, review, and approve qualification and validation activities


• Develop, review, and approve qualification and validation documentation, including protocols, reports, risk assessments, validation plans, and associated records.


• Perform qualification activities for facilities, utilities, equipment, and computerized systems, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)


• Participate in the management of quality system processes, including deviations, investigations, CAPAs, change controls, and risk assessments


• Support the development, review, and maintenance of quality and validation procedures


• Support internal audits, customer audits, and regulatory inspections


• Identify opportunities to improve quality systems, validation processes, and ways of working.


• Promote a culture of quality, compliance, continuous improvement, and inspection readiness throughout the organisation

About you:

• Tertiary education in Science, Engineering or Pharmaceutical Science


• Minimum of 3 years’ experience working within a GMP-regulated pharmaceutical,complementary medicines, nutraceutical, medical device, or other regulated manufacturing environment


• Must have strong experience in sterile processing and pharmaceutical manufacturing


• Problem solving, creative thinking, and effective decision-making skills


• Excellent communication skills, detail oriented and team collaboration.


• Experience with qualification and validation of facilities, utilities, equipment,processes, cleaning programs, and/or computerized systems