Rajesh Surada

PRODUCT:

• Darbepoetin Alfa
• Rituximab
• Bevacizumab
• Zoetis products
• Stem cell mAbs
• F-mAb
• Trastuzimab
• Aflibercept mAb

EQUIPMENT:

• Cytiva Single Use Bioreactors (up to 500L integrated with Wonderware software's)
• Thermo Single Use Bioreactors (up to 2000L with Finesse TruBio DeltaV)
• Wave Bioreactors (Sartorius 10 & 25L)
• Single Use Mixers (Thermo) scale of 50L to 2000L
• Stainless steel Bioreactors (Bio Engineering Systems & Sartorius up to 2000L)
• Media and Buffer preparation vessel (DD Enterprise - 1500L)
• Incubators – Kuhner
• Cell Counters – Beckman Coulter, Cedex HiRes
• Bioanalyzers – Nova Bio profile analyser, Cedex Bioanalyzer
• Bio welder & Bio sealer – Sartorius
• Depth Filters & POD filter system - PALL
• Cryoplus LN2 Systems

• CIP Station and CIP Skid
• Filter Integrity – Pall, Sartocheck 4 Plus
• Osmometers – Gonotec & Advanced Instrument

TROUBLESHOOT:

• Analyzing and resolving equipment, process and operational problems in effective and timely manner

CGMP:

• Delivers accurate, error-free work meeting strict standards

TEAM MANAGEMENT:

• Organizing workflow by assigning responsibilities and preparing work schedules to meet production targets

COMMUNICATION:

• Acted as key point of contact for cross functional teams to coordinate cross functional activities and for smooth functioning of operations to achieve departmental objectives

DOCUMENTATION:

• Preparation of Process Consistency Protocol & Report
• Preparation of Standard Operating Procedures (SOP's), Batch Manufacturing Records (BMR's), Qualification protocols like URS, CLIA, SLIA, DQ, PQ & IOQ Review, maintained & submitted documents on time

QUALITY MANAGEMENT SYSTEM (QMS):

• Handled QMS activities like Change controls, Implementation Plans, CAPA, Gap Assessments, Risk Assessment & Deviation Investigations and related report preparation

QUALIFICATION:

• Drove qualification activities IQ, OQ & PQ for all upstream related equipment's

SAP:

• Batch postings and create process orders (PO), reservations for process related stationeries, create maintenance notifications for engineering department

TRAINING:

• Create & gives trainings to team members in e-Learning Management System(e-LMS)