Randstad | Quality Assurance- Validation Specialist | Melbourne
vor 23 Stunden
Quality Assurance- Validation Specialist Randstad has been given the exclusive opportunity to recruit for a new role of a Quality Assurance, Validation Specialist for our Pharmaceutical Clients based in Central Melbourne.
Reporting to the Quality Assurance Operations Senior Manager, this opportunity will give you the chance to join a well established pharmaceutical brand assisting with compliance with process, utilities, equipment and computer system validation.
This role will play a pivotal role in the quality team, and has the potential for growth opportunities in future
ABOUT THE ROLE
Monitor and validate critical control points to ensure compliance with quality standards.
Quality Validation representative or site project execution for the oversight for the commissioning, qualification and validation of new manufacturing equipment, rooms, utilities, automation, computer systems, cleaning validation program and laboratory.
Evaluate and approve qualification and validation documentation such as risk assessments, protocols, reports.
Ensuring compliance with quality procedures.
Participate in cross functional meetings for planning and discussing changes to be commissioned, qualified, validated of equipment/facilities/utilities.
Ensure a strong partnership with cross function teams such as Commissioning Qualification Validation (CQV) team, Facility engineers, vendors and project Automation representatives to problem solve.
Review, evaluate and approve deviation, discrepancy and changes control that occurred throughout qualification/validation of equipment/systems in area of responsibility.
WHAT YOU WILL BRING
Ideally 2-5 years of experience in a similar role - Preferably in Validation.
Minimum education requirement is a Bachelor's degree, preferably in Sciences or Engineering.
Working knowledge of QA principles, knowledge of cGMPs, validation principles, industry practices, and ability to apply these to GMP operations.
Demonstrated strong ability in problem solving, ability to effectively interact with all levels of personnel in the organisation.
Demonstrable experience with Change Control, Deviation Management and Risk management Quality Systems.
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