Your new company

This is an exciting, growing organisation leading the way in their field. They are looking for a QA/Validation professional to join their small but expanding team based at their manufacturing site in the southwest of Western Australia. The person will need to be located there or be willing to relocate for an excellent opportunity offering growth and development.

Your new role

Your role will be to ensure that all equipment, processes and systems meet regulatory compliance and quality standards.
This will include but not limited to;

Validation Activities:

• Develop, execute, and review validation protocols (IQ, OQ, PQ) for equipment, processes, utilities, and computerised systems.
• Perform risk assessments to identify critical control points and ensure validation plans address them.
• Maintain validation schedules and ensure timely revalidation of processes and equipment as required.
• Troubleshoot validation challenges and collaborating with cross-functional teams, including QC, to implement solutions.

Quality Assurance:

• Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements, such as FDA, TGA, or EMA.
• Develop and update Standard Operating Procedures (SOPs) related to QA and validation activities.
• Conduct internal audits and assist in regulatory inspections to demonstrate compliance.
• Manage deviations, CAPAs, and change controls associated with validation and QA processes.
• Collaborate with the QC department to address any quality issues identified during testing, ensuring alignment between validation and quality control processes.

Documentation:

• Prepare comprehensive validation reports and ensure proper documentation of all validation activities.
• Maintain accurate and organised records of quality and validation-related documentation.
• Review and act as a delegate for the QA & Regulatory Manager in approving technical documents, including validation protocols, reports, and batch records, ensuring compliance with regulatory and quality standards.

What you'll need to succeed

• Tertiary qualified in science related field

• Experience working in the pharmaceutical industry

• Knowledge of Validation principles, IQ, OQ,PQ

• Knowledge of TGA FDA, EMA

• Full working rights

• Attention to detail

• High level communication skills

What you'll get in return

An exciting growing organisation in a small market to grow and develop in your field. You will work for a company leading the way in the pharmaceutical industry. The role also offers a competitive salary and potential relocation package.

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.

LHS 297508