Baskaran Bangaru

• Ongoing Sterile Manufacturing Facility Project:
• URS, Sortware design using Siemens PCS7 in coordination with siemens engineer for CIP, SIP Pressure test and other formulation sequences using approved valve matrixes.
• FAT, SAT, IOQ, Cycle development & PQ of Formulation vessels for its CIP, SIP, Pressure test and various Formulation sequences using Siemens PCS7 software.
• Isolator Filling line- Including Bausch Stroebel & Franz Ziel Isolator Filling machine & Formulation Vessels package with Siemens PCS7 software.
  Valve matrix design & Handling ongoing FAT, SAT, IOQ, PQ of Isolator Filling machine, Atec Component processor cleaning and sterilization cycle valve matrix design and cycle development.
• Facility qualification and qualification of equipment's by referring regulatory guidelines such as FDA, MHRA, EMA, ISPE and USP which includes clean utilities, HVAC system, formulation vessels, Autoclave, Vial/cartridge washing, tunnel, filling and sealing machine
• Responsible & SME for RABS Bosch Filling machine & Formulation of sterile manufacturing for ongoing commercial line since 2013 (Line-1).
  Handling of quality management system including Change Control, CAPA, Deviation using Trackwise tool.
  Managing day today production activities
  Handling of Regulatory audits
• Scale up, commercialization and development of products
• Smoke Study for Filling machine: Performing Periodical AFV & Performing AVF based on the regulatory requirement (In-operation & At rest)
• Preparation of protocol, Performance, and Video compilation & edition and report approval as per the timeline
• Audits faced & Succeeded: USFDA, EMA, ANVISA, Health Canada, Saudi-FDA, NPRA

SAP: As a super-user on SAP for production module, starts from

BOM creation till TECO. PR creation and costing update to

finance every quarter. Batch Release. Implemented business process

Integration.

Additional Responsibility: MES project Lead for Drug Product

department. MES software design & Development, IOQ of

software , PQ. MES project development using WERUM PAS-X

software, Including SAP Integration, Weighing & Dispensing

Integration, E-Log books integration, E-BMR integration,

• Aseptic Lab Set-Up for the university: Planning and procurement of Aseptic lab equipments, commissioning of autoclaves, Mobile LAF, air showers, and pass boxes for the University laboratory
• Inventory of Laboratory equipment & chemical and arranging vendor for periodical calibration/qualification
• Preparation of Procedures and trainings
• Lecturing of Pharmacy students on various subjects.

• Review and refine the draft of clinical Safety reports with MSAP development of Aggregate Safety Reports.
• Conduct Analysis of single cases with study physicians to determine the relevant section PSUR.
• Create documents in accordance with applicable Standard Operating Procedures, conventions and BMS policies.
• Prepared reports summarizing research results for presentation to colleagues and management.
• Plan, organize & manage daily work to meet service level timelines and deliverables.

• Collection, Preparation and submission of safety reports to the Sponsor, SRC, and CEC
• Justifying the safety reports to the regulatory team based on the study conducted
• Compilation of CIOMS/SAE reports in the desired format for regulatory submission
• Study site start-up, Site feasibility & study initiation
• Management of Informed Consent Form & amendments
• Patient recruitment, screening for eligibility & Patient follow-up
• Coordinating with Principle Investigator & Monitoring the sites.

• Oral Liquid Preparation and Capsules:
• Planning for batches in coordination with the production head
• Preparation Review of SOPs, BMR & Protocols
• Maintaining Raw material inventory, Calculation, and dispensing of materials
• Handling of Fill-Finish equipment & Overseeing Formulation and Filling activities
• Overseeing Visual Inspection and Packing of Oral Liquid Preparation and Capsules
• Troubleshoots Filling and Capsule machine.