Quality Assurance Validation Specialist
1 month ago
Randstad has been granted the opportunity to recruit for a Quality Assurance, Validation Specialist position in Central Melbourne.
This role will report to the Quality Assurance Operations Senior Manager and offer the chance to join a well-established pharmaceutical brand. The candidate will be responsible for ensuring compliance with quality standards and processes.
About the Role
- Validate critical control points to ensure compliance with quality standards.
- Promote and implement qualification and validation of new manufacturing equipment, rooms, utilities, automation, computer systems, cleaning validation program, and laboratory.
- Evaluate and approve qualification and validation documentation, including risk assessments, protocols, and reports.
- Guarantee adherence to quality procedures.
- Participate in cross-functional meetings for planning and discussing changes to commissioned, qualified, or validated equipment/facilities/utilities.
- Maintain strong partnerships with cross-functional teams, including Commissioning Qualification Validation (CQV), Facility engineers, vendors, and Automation representatives to resolve problems.
- Review, evaluate, and approve deviation, discrepancy, and change control that occurred during qualification/validation of equipment/systems within their area of responsibility.
What You Will Bring
- A minimum of 2-5 years of experience in a similar role, preferably in Validation.
- Bachelor's degree, preferably in Sciences or Engineering.
- Working knowledge of QA principles, cGMPs, validation principles, industry practices, and ability to apply these to GMP operations.
- Demonstrated problem-solving skills and effective interaction with personnel at all levels.
- Experience with Change Control, Deviation Management, and Risk Management Quality Systems.
The salary for this position is estimated to be around $90,000-$110,000 per annum, depending on experience. At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to our benefit.
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