Pilli Ratnaraju

Job Responsibilities:

•Preparing and implementing Commissioning and Qualification Master Plan for new drug substance manufacturing facility and expansion.

•Reviewing and approving of User requirement specification, system-level impact assessment, Design qualification, Criticality level impact assessment for utilities, compressed gases, autoclave, vessels, RPHPLC, Crystallizers, fermenters, rotatory incubator shakers , warehouse storage areas, temperature controlled equipment cold room, deep freezers, walk in incubator, walk in stability chambers.

• handling of equipment qualification like thermal mapping for temperature controlled units, ovens, cold rooms , BOD Incubators, Walk in coolers.

• review and approving of CSV test scripts as part of initial qualification and periodic review.

•Spearheaded Commissioning and Qualification (C&Q) activities for autoclaves, fermentors, water systems, utility systems, AHUs, and Lyophilizers (LYO).

•Successfully developed and executed comprehensive validation protocols (IQ/OQ/PQ) for diverse equipment, ensuring compliance with regulatory standards and internal SOPs.

•Collaborated cross-functionally to ensure the alignment of C&Q activities with project timelines, resulting in timely project delivery •Managed C&Q projects for various systems, including autoclaves, LYO, fermenters , water system , ensuring adherence to GMP and industry best practices.

•Conducted thorough risk assessments and root cause analyses to identify and mitigate potential quality and compliance issues, ensuring proactive solutions.

•Led and mentored a team of validation engineers, providing technical guidance and fostering a culture of excellence in C&Q practices.

•Managed Computer System Validation (CSV) projects, ensuring data integrity and compliance for critical systems.

Job Responsibilities:

• Review and approval of Design Qualification protocols from Vendor and In-house protocols.
• Support during preparation of URS.
• Review of Design qualification, FAT, SAT, IQ, OQ, and PQ documents.
• Review and approval of qualification documents of equipment’s which are using for the preparation of the
complex injectable. (Multivessel Skid, Agitated nutsche filter dryers (ANFD), Autoclave, Dry powder handling
Isolator).
• Preparation and review of facility qualification documents.
• Review and approval of Installation, Operational, Performance and Re Qualification protocols and reports.
• Co-ordination with cross functional team activity planning.
• Co-ordination with respective department to complete qualification activity within timeline.
• Preparation of Investigation and closing of the incidents raised during the qualification execution.
• Preparation and review of risk assessments for the process equipment.
• Preparation and review of the annual validation plan.
• Preparation and review of HVAC, LAF, DPB protocols and reports.
• Preparation and review of Utilities protocols and reports (PSG, Nitrogen and compressed air)
• Extensive Use of KAYE validator
• Initiation and closure of change controls and related validation activities.

• Job Responsibilities:
• Review and approval of Design Qualification protocols from Vendor and In-house protocols
• Support during preparation of URS
• Involve in Factory Acceptance Test, Site Acceptance Test
• Review of Design qualification, FAT, SAT, IQ, OQ, and PQ documents
• Review and approval of qualification documents of equipment’s (Autoclave, lyophilizer, vial washing machine, Pre filled Syringe, Manufacturing Vessels, Filtration Vessels, tunnel, vial filling and stoppering machine, vial sealing machine, HVAC documents)
• Review and approval of Installation, Operational, Performance and Re Qualification protocols and reports
• Preparation and review of Standard operating procedures related to Validation activities
• Preparation and review of the annual validation plan
• Preparation of Master equipments list
• Review of logbooks
• Review of CSV documents
• Preparation, review and approval of Validation Protocols
• Preparation review and approval of Validation Reports
• Review and approval of executed documents
• Initiation and closure of change controls and related validation activities
• Transport validation activities
• Preparation and review of HVAC protocols and reports.

• Job Responsibility:
• Preparation, Execution & Review of OQ, PQ & RQ protocols and reports of equipment / facility
• Investigation and closing of the incidents raised during the activities
• Participation during regulatory and customer audits
• Validation of manufacturing vessels, bulk holding vessels
• Validation of vial washing machine, Validation of depyrogenation tunnel
• Validation of steam sterilizer, terminal sterilizer
• Validation of lyophilizer
• Validation filling and stoppering machine (Bausch and strobel), vial sealing machine
• Validation of product transfer system
• Qualification of area by validating the AHUs, LAFs, pass boxes
• Active participation in internal audits along with the cross functional groups
• Review of all qualification documents pertaining to equipment’s and utilities
• Validation of labelling and packaging system
• Validation of Track and Trace (Serialization) system
• Validation of sterility test Isolator
• Validation of water system and pure steam generation, Nitrogen Compressed air Generation and distribution system
• Audits Exposure:
• USFDA – 2017 (APR)
• TGA – 2017 (MAY)
• MHRA – 2017 (DEC)
• USFDA – 2018

• Job Responsibility:
• Validation of all Process Equipment’s and Area
• Involved in Cleaning Validation activities
• Involved in Process Validation
• Validation of OSD Equipments
• Preparation of BMR and BPR
• Trained on Track wise software for documenting the Deviations, CAPA`s, change control
• Time management and determination towards assigned work
• Willingness to learn and update myself.