Qualification Program

The Qualification Program (IQ/OQ/PQ) Administrator is responsible for overseeing the installation, operational, and performance qualification of equipment and systems in compliance with regulatory standards. This role ensures that all equipment operates within specified parameters and meets quality and safety requirements., Verify that equipment is installed according to manufacturer specifications and site requirements. Document the installation process, including utility connections, environmental conditions, and component verification. Ensure all necessary documentation, such as manuals and certificates, are available and complete. Develop and approve OQ protocols that outline the tests to be performed to verify equipment operation. Conduct tests to ensure the equipment operates according to predefined specifications under normal operating conditions. Document test results, any deviations, and corrective actions taken. Develop and approve PQ protocols that outline the tests to be performed to verify equipment performance under actual production conditions. Conduct tests to ensure the equipment consistently performs according to specifications. Document test results, any deviations, and corrective actions taken. Ensure all qualification activities comply with local and international regulatory standards, such as FDA and cGMP guidelines. Stay updated on changes in regulations and adjust qualification protocols accordingly. Develop and conduct training programs for staff on IQ/OQ/PQ procedures and protocols. Promote awareness of qualification processes within the company. Implement monitoring systems to ensure adherence to qualification protocols. Conduct regular internal audits to identify areas for improvement and ensure compliance. Maintain detailed records of all qualification activities, including protocols, test results, and corrective actions. Ensure documentation is accurate and easily accessible for regulatory inspections.”, 1 Establish the requirements (IQ) 2 Approval of the Protocol (IQ) 3 Execution of the IQ 4 Documentation of IQ Protocol 5 Post protocol review 6 Complete the IQ 7 Summary of IQ activities 8 Initiate and review OQ requirements 9 Approval of OQ Plan 10 Execution OQ and Test Plan 11 Completion and Verification of Training OQ 12 Verification of Equipment OQ 13 Deviation Identification OQ 14 Record and Resolve Deviation OQ 15 Re-execute Failed Portion of OQ 16 Documentation of OQ Protocol 17 Completion of all OQ Requirements 18 OQ Protoccol review approval 19 Creation of Quality Summary Report (IQ/OQ) 20 Initiate and Review PQ requirements 21 PQ Plan approval 22 Executing the PQ Protocol 23 Process Verification PQ 24 Completion and verification of PQ training 25 Deviation Identification PQ 26 Record and Resolve Deviation 27 Re-execute Failed Portion of PQ Protocol 28 Completion of the PQ 29 Quality Approval PQ 30 Stakeholders Approval PQ” What are the Mandatory skills and skill proficiencies required for this position?

Bachelor’s degree in engineering, Life Sciences, or a related field. 3-5years of experience in equipment qualification or validation in a regulated industry. Strong knowledge of IQ/OQ/PQ processes and regulatory standards. Excellent analytical and problem-solving skills. Strong communication and interpersonal skills. Experience with cGMP and FDA regulations. Proficiency in data analysis and reporting tools. Ability to work collaboratively with cross-functional teams.