Sivasankar Reddy Mopuru

• Successfully completed (April-2022) USFDA audit without any observations, and I was played as key role as GLP section in-charge
• Preparation and review of specifications and test methods (STM's) as per current monographs and as per customer requirement
• Preparation and review of SOP’s for new equipments, for better efficiency
• Trainings on new STP, SOP’s, scheduled trainings to develop the good laboratory practices in laboratory
• Customer audit response against observations and fulfill the gaps of audit within the timelines
• New instrument/equipment qualifications
• Responsible for planning and monitoring of sampling, distribution of samples
• Planning for analysis of all types sample and release within timelines
• OOS, OOT, LIR, AER Investigations
• To support for new software installation and upgradation for IT persons
• Monitoring and review of audit trails in software systems to meet the 21 CFR requirements
• Backup data monitoring through data retrieval and verification.
• Responsible for to maintain calibration schedules for monthly, quarterly, Hal-Yearly and Yearly
• Responsible for Preventive maintenance as per schedule, with support of external service engineer
• To verify the data integrity issues
• Responsible for external calibration with outsourcing agencies
• Responsible for working standard management
• Performing the internal audits for QA and Production departments
• New Employees training and analyst qualification, re-qualifications
• Incident investigations and impact assessment
• Working on reducing the documentation with simplification of SOP’s and STP’s.

• Working in GLP section as a supervisor
• SOP preparation & Trainings through EDMS and LMS software’s
• Prepare the new SOP’s and protocols for new projects
• Certified trainer for GxP topics presentation
• Justification to all cross functional reviewers team for SOP revision
• Reference standard and working standard management
• Internal calibration reports review and Approval; External calibration certificates review
• Monitoring of AMC schedule of QC Instrument
• In house maintenance of QC Equipment’s / Instrument
• Column management
• Day-to-Day co-ordination with all departments
• Gap assessment against GQS, GSOP, Audit Query, CAPA’s
• Awareness creation on trainings
• Change controls and CAPA through TrackWise system
• Participate in cost saving projects
• Monitoring the calibration and PM schedule
• Supervisor privilege for Method editor in Empower software
• SOP and online job training through LMS system and manual for concerned persons
• Active role for audit preparations
• Responsible for Regulatory queries through LIMS
• Actively participated in USFDA (2018, 2019 & 2020)& WHO Audit success
• Risk assessment for instruments software’s
• Award: Received appreciation Thank you note from Head-QA in SUN Pharma for SOP’s preparation within the timelines and new SOP’s preparation.

Overall Quality Functions with team of 20 members.

• National and International Research papers published.
• Thesis write up completed
• Got Ph.D award in Aug-2016

• Update the daily report for finished goods, intermediates and raw materials
• Receiving and review all analyzed protocols & prepare the COA’s and entered & approved in ERP system and sent to QA
• Maintain and reviewing documentation such as laboratory notebooks, instrument log books, training records, etc
• Ensure compliance of various measures such as GLP by maintenance of appropriate documentation/records
• Maintain and reviewing of instrument calibration records
• Monitoring the control sample and their records
• Audits co-ordinated: USFDA, MHRA, EDQM, TGA and customer audits
• As analytical chemist
• Analysis of finished goods by using HPLC, UV, FT-IR, PSA and DSC
• Calibration of laboratory instruments (HPLC, UV, SOR, IR spectrometer)
• Analysis of raw materials and intermediates
• Maintenance of volumetric solutions
• Handled shift wise analysis
• Initiate and rising of all incidents, OOT and OOS reports.
• Worked well in a team setting, providing support and guidance.

• As analytical chemist
• Receiving the in-process samples and entered in log book and generated A.R
• No
• Analysis of reaction monitoring samples by TLC and GC
• Analysis of raw materials and intermediates by using UV-Visible, FT-IR, SOR
• Maintenance of volumetric solutions
• Maintain the control sample and stability samples storage conditions and recording the chambers conditions
• Review and maintain documentation of in-process TIR’s
• Complete wet analysis for raw materials, intermediates and API’s
• Instruments Handled:
• HPLC (Waters with Empower software and Dionex with Chromeleon software)
• GC
• FT-IR and UV-visible spectrometers
• Particle size analyzer by Malvern
• Auto-titrators and Polarimeter