QA Operational Readiness Officer

Join our cutting-edge client and help with revolutionising the future of biologics within this quality assurance position!

R&D Partners is seeking a QA Operational Readiness Officer to support the successful startup and commissioning of a new production facility. In this role, you will ensure quality readiness, operational excellence, and compliance with regulatory standards during the transition from construction to operational status.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Provide on-the-spot quality support to project teams.
• Review and address quality issues, including investigations, root cause analysis, and corrective actions.
• Ensure timely documentation and approval of changes impacting quality.
• Conduct regular site inspections to ensure compliance.
• Maintain and update quality management system documents.
• Oversee quality readiness plans for the new production facility.
• Perform assessments to identify gaps in quality systems and processes.
• Collaborate with teams across manufacturing, supply chain, and regulatory functions.
• Support facility qualification activities, including equipment and system testing.
• Assist with regulatory submissions and inspections.
• Identify and mitigate risks related to new processes and procedures.

Key Skills and Requirements:

• Background in Life Sciences, Engineering, Quality Management, or a related field.
• Familiarity with Good Manufacturing Practices (GMP) and pharmaceutical quality systems.
• Strong problem-solving and analytical skills.
• Effective communication and teamwork abilities.
• Knowledge of pharmaceutical manufacturing processes and technologies.
• Ability to manage multiple tasks in a dynamic environment.

For more information, please contact Grant Van Schalkwyk.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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