Razi Khan

Assisted CQV review, ensuring alignment with Transition Group on Turnover Packages approval.

Reviewed and approved System User Requirements via Kneat and Veeva.

Evaluated and sanctioned C&Q document preparation, including Plans, Test Protocols, and Reports.

Approved contractor and vendor handover documentation for compliance.

Reviewed systems at Mechanical Completion for adherence to standards.

Assessed C&Q field execution processes, including FAT, SAT, RV, IV, and FT.

Executed recipes, sequences, and functional testing using DCS to ensure operational readiness.

Managed Project Change Control and Discrepancy Management through Trackwise.

Designed and archived C&Q documentation, including IQ, OQ, PQ protocols and reports.

Managed qualification and test plans in accordance with technical requirements and traceability matrices.

Executed drafting, verification, and execution of FAT, SAT, IQ, OQ, and PQ protocols.

Directed Qualification aspects of changes and projects based on guidance from Process Engineers.

Collaborated with external customers to align Qualification strategies and resolve compliance issues.

Resolved deviations related to Qualification activities and supported issue resolution processes.

Formulated Qualification strategy by consulting with Production, Engineering, and Quality representatives.

Prepared Qualification schedules aligned with project requirements in coordination with Process Engineer.

Coordinated design changes through Client-approved change control procedures, ensuring compliance with cGMP standards.

Generated, reviewed, and approved project documentation, including Scope and User Requirement Specifications.

Supported validation activities by reviewing documentation and attending FAT, IQ, and OQ as required.

Ensured procurement of new equipment adhered to site procedures and regulations.

Provided technical support for system end users, troubleshooting issues and assisting with process investigations.

Created, reviewed, and approved validation documents for Fridges, Freezers, and Liquid Nitrogen Tanks.

Reviewed and approved sterilization protocols using vaporized hydrogen peroxide for isolators.

Maintained equipment and environments for operational readiness, contributing to deviation investigations as needed.

·Defined design criteria and user requirements collaboratively with clients.

Conducted process calculations, simulations, and equipment sizing for optimal performance.

Reviewed and approved commissioning and qualification of bio equipment and systems.

Generated and executed IQ/OQ protocols to ensure compliance.

Evaluated vendor documents for commissioning and qualification of fridges, freezers, and liquid nitrogen tanks.

Assessed isolator technology and equipment for regulatory adherence.

Coordinated vendor clean utilities packages to enhance CQV processes.

Ensured all onsite equipment met FDA/MHRA standards through rigorous review.

Created, reviewed, and approved Site Engineering Specifications, ensuring content and format compliance.

Promoted sustainable design solutions through active participation in Design Sustainable Reviews.

Ensured commissioning readiness of all systems for Utilities start-up and IOQ testing.

Conducted quality reviews of SUS documents from vendors to maintain standards.

Reviewed and approved qualification documentation for production and laboratory equipment.

Performed risk assessments on revalidation frequency for various instruments and equipment.

Executed quality reviews of IQ, OQ, PQ protocols for cold storage and bioreactor systems.

Reviewed validation statuses of instruments, generating comprehensive summary reports.

• Conducted prototype development to evaluate new design concept feasibility.
• Performed comprehensive gap analysis, facility fit studies, and process safety evaluations.
• Analysed process data during manufacturing operations to maintain efficiency.

Updated specifications pertaining to NPI materials while ensuring compliance.

Facilitated commissioning of systems to support utilities start-up and IOQ testing.

• Managed multiple projects, ensuring timely completion and high-quality work.

Validated downstream equipment including clean gases and CIP systems during commission phase.

Developed critical acceptance criteria along with PURS and GURS documentation.

Managed progress reviews, adhering to agreed schedules while supporting change control.

• Coordinated with cross-functional teams throughout project development phases.

Served as work package owner for utility project teams.

Reviewed and approved designs for utility generation and distribution systems.

Assessed P&IDs for critical utility systems, including WFI, Purified Water, CIP, and Process Gases.

Oversaw installation and supervision of clean utilities.

Executed FAT/SAT processes efficiently.

Developed and reviewed URS documentation.

Approved modifications and change requests for Utility & HVAC systems.

• Streamlined workflow by implementing efficient task management strategies.

• Facilitated design reviews to enhance product quality.

Coordinated equipment calibration exercises, ensuring high accuracy levels.

• Conducted comprehensive data analysis to support informed decision-making.

Managed change processes to guarantee cost-effective and timely implementation.

Collaborated with project managers, engineering, and QA teams for seamless interactions.

Generated and planned CQV timelines alongside CQV manager and project managers.

Supported startup commissioning and qualification programmes, including clean utilities.

Reviewed technical requirement specifications and vendor turnover documentation for compliance.

• Resolved intricate engineering problems through innovative solutions.
• Collaborated with cross-functional teams to enhance validation processes.
• Maintained documentation of validation activities to ensure transparency and accountability.
• Achieved optimal production levels by implementing efficient test automation techniques.

Reviewed all design deliverables including drawings, datasheets, specifications, and engineering lists.

Served as point CQV representative for vendor reviews of all assigned packages.

Led CQV review in coordination with Transition Group for approval of turnover packages.

Facilitated communication with CQV team regarding punchlist closure and schedule management.

• Developed robust validation strategies for improved production efficiency.
• Assisted in design reviews for increased product quality.
• Drafted detailed reports for effective communication of test findings.
• Enhanced system reliability by executing comprehensive testing protocols.
• Worked with production teams to facilitate smooth transition from design and testing to full-scale Packaging.

Liaised with clients to translate needs into technical requirements.

Acted as work package owner with utility project teams.

Reviewed design documentation to ensure compliance with CQV and cGMP standards.

Participated in project start-up activities, preparing Installation Verification and Operational Verification documents.

Coordinated with construction and contractors for effective mechanical and E&I system handover.

Generated documentation and reviewed vendor materials during design development stage.

Commissioned and qualified Clean Utilities, including Compressed Air, Nitrogen Gas, and WFI Systems.

Resolved commissioning and validation issues with minimal supervision.

• Facilitated productive client meetings, ensuring clear communication of complex technical concepts.
• Cooperated with cross-functional teams throughout project development stages.
• Conducted research to maintain awareness of latest industry trends and technologies.

Led GMP equipment asset owners, managing complete GMP lifecycle from URS to operational use.

Promoted strong quality and compliance activities, addressing cGMP deficiencies promptly.

Managed capital projects, overseeing planning, execution, and documentation processes.

Reported progress, priorities, and timelines to management while sharing critical information.

Contracted and managed external vendors to fulfil business requirements.

• Oversaw installation, testing and commissioning of engineering systems to meet performance and safety requirements.

• Conducted regular site visits to oversee construction process and progress.
• Coordinated with other engineers and professionals on large scale projects.
• Cooperated with cross-functional teams during project development stages.
• Delivered cost-effective solutions for complex engineering problems.

■ Lead validation initiatives for critical utility systems, such as purified water, HVAC, and clean utilities,

to ensure reliable and compliant operation.

■ Generation/maintenance/execution of Project Commissioning and Validation Plans and schedules.

■ Review and generation of Commissioning and validation protocols and final reports of Equipment and Clean Utilities to cGMP standards.

■ QA support for validation investigations and implementation of corrective actions.

■ Creation/Review/Approval of various validation and qualification documents

■ Management of validation, exception event, and change control processes.

■ Documenting all activities in line with cGMP requirements.

■ Review and Execution and/or Witnessing of Site Acceptance Test / Commissioning protocols.

■ Generate Installation / Operational Qualification protocols.

■ Review and Execution and/or Witnessing of Installation Qualification protocols.

■ Review and Execution and/or Witnessing of Operational Qualification protocols.

■ Coordination of C&Q witnessing activities.

■ During the execution phase, arrange daily meetings to ensure schedule is being progressed as agreed..

■ Review and approval of Validation Documents. (URS, FAT/SAT, DQ, IQ, OQ, VMP and Validation Summary Reports)

Functioned as key member of CQ Team, guiding Clean Utilities Systems implementation.

Reviewed and approved commissioning and qualification protocols for bioreactors, compressed air, nitrogen, and HVAC systems.

Conducted functional testing of equipment within API manufacturing plant.

Prepared and reviewed commissioning documents, including water and solvent batch testing.

Interfaced with project team representatives, construction, engineering, vendors, automation, quality, and end users.

Ensured safe testing and commissioning of installations to meet performance requirements.

Scheduled and coordinated onsite commissioning activities, adhering to tight deadlines.

Monitored progress, recorded test results, and compiled all documentation.