Khaled Rifai

• PM/Project Quality Manager (PQM)/Sr. CSV/CSA Lead with Scrum Master expertise.
• Led cross-functional matrix teams ensuring implementation of new corporate SOPs for CSA and digital integration, utilizing tools like Kneat and ValGenesis.
• Authored functional risk assessments, 21 CFR Part 11, data integrity, and mitigation strategies.
• Managed change controls ensuring adherence to SOPs.
• Capably coached others on problem-solving techniques and validation methodologies.

Alcon Laboratories, (All Alcon Sites)

07/2005 – Present

PQM for various projects:

• MES (Siemens, Werum) including integration w/ SAP, LIMS, and Machines (PLC/SCADA).
• SAP IRIS system Implementation.
• Transition of Operational Technology (OT) applications (Novartis to Alcon Infrastructure)
• Global LIMS (LabVantage) including integration w/ connect instrument drivers, SAP and MES.
• BI Reporting and Data Lake.

Responsibilities:

• Authored Validation Plans, User Requirements Risk Assessment (URRA), Functional Requirements, System Design/Configuration Requirements, IQ/OQ/PQ Test Plans & Scripts and Validation Summary Reports. Reviewed, approved, and provided CSV/CSA guidance on other SDLC documents.
• Managed all OT applications and associated computer system changes.
• Led team of 12 SAP developers and CSV resources while being liaison between various business units and core SAP team.

• Developed CSV SOPs and workflows to address Change Control Operations.
• Streamlined change control processes by implementing automation scripts, increasing efficiency in daily tasks by 25%.

• Successfully managed multimillion-dollar client-critical electrical, automation and controls projects, directing both local and external resources.
• Prepared detailed system specifications, documented customer requirements, and maintained adherence to electrical standards
• Executed comprehensive validation processes, including FAT, IQ/OQ, and SAT, to meet regulatory standards (21 CFR Part 11, CSA, cGMP, FDA).
  

• Partnered with other Co-Managers @ https://coffeetime.com/ to share best practices, learn from collective experiences, and improve overall store performance.
• Ensured compliance with company policies, procedures, and safety regulations by monitoring operations on a daily basis.
• Resolved complex customer complaints promptly and effectively, maintaining high levels of customer satisfaction while protecting business interests.
• Managed inventory control, ensuring optimal stock levels while minimizing shrinkage and wastage.
• Increased sales revenue by training and mentoring staff in effective selling techniques and product knowledge.
• Improved employee retention rates by fostering a positive work environment through team-building activities and open communication.
• Acted as a key liaison between employees and management, facilitating open communication channels and addressing concerns in a timely manner.
• Managed scheduling for all employees to ensure adequate coverage during peak periods without compromising labor cost objectives.