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Sailaja Dondeti

Sailaja Dondeti

QC Microbiologist at AbbVie
Singapore

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About Sailaja Dondeti:

Experienced Microbiologist working in the Quality Department, hardworking, competent, and responsible person eager to establish a long-term relationship with a company where I would apply my extensive knowledge in order to achieve the organization's as well as my personal goal and to work to learn, learn to work and intend to build a career with committed & dedicated people, which will help me to explore myself fully and realize my potential.

Experience

PROFESSIONAL EXPERIENCE   

MICROBIOLOGIST I - AbbVie Biologics Singapore (ABS) Jan 2021 to till date (Full-time)

Responsibilities:

  • Perform routine/non-routine quality monitoring, Sampling and testing of Utility systems inclusive of Purified water, Water for Injection, Pure steam. This include participate in trouble shooting activities for Utility systems and clean rooms.
  • Perform in-process and release samples testing of excipient/ packaging components for the different drug products, semi-finished drug product and Final drug substances. i.e., Sterility test, Bacterial endotoxin test, Bioburden test, Microbial Limits Test, etc., as appropriate.
  • Oversee the Calibration and Preventive Maintenance of Lab equipment’s as a SME.
  • Ensure completion of periodic reviews of SOPs. This includes documentation support to the department by participating in writing/revising of SOPs, protocols, Test reports.
  • Review and approve test reports Logbooks, data sheets that are generated in microbiology lab.
  • Perform Media Receival, Sterility check and Growth Promotion Tests for media used for testing.
  • Perform initial Quality Control check and regular QC checks on ready-to-use cultures and maintenance of cell cultures.
  • Maintain Inventory management and continuous supply of laboratory consumables. Solicit quotations of laboratory consumables.
  • Lead Periodic Evaluation of Alert Limits based on the historical data as per established procedures. 
  • Maintain up-to-date, Complete and precise records of all tests performed.
  • Leading the QC Micro Cost Savings Project.
  • Train laboratory team in operational tests and sampling methods.
  • Participate in and support audit preparation and audit responses, including the development and implementation of programs to provide timely follow up on correctives and commitments.
  • Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable. Support CI initiatives and laboratory performance metrices.
  • Officially appointed as Occupational First aider at Abbvie EHS.
  • Carry out training as per training plan. Perform technical competency assessment for trainee.

MICROBIOLOGIST - No Deviation Pte Ltd Mar 2017 to till Dec 2020 (Full-time)

Client - AbbVie Biologics Singapore (ABS) 

Responsibilities:

  • Perform Routine/Non-routine sampling and testing of utilities (WFI, clean-steam PURW,POTW) and Batch related Environmental monitoring (EM) Viable and Non-viable particle sampling, surface and settling plate sampling in clean rooms and production areas as per standard workflow schedule.
  • Qualified and performing QC laboratory testing of contamination check samples, raw materials, in-process and Final BDS Bioburden and Endotoxin testing of product samples by following SOP’s and according to cGMP guidelines. 
  • Carry out environmental and material microbiological tests as required.
  • Prepare quarterly trending reports and data evaluation for both environmental, water, and clean utilities monitoring.
  • Documentation support as SME and maintain up-to-date, complete, and precise records all the test methods as per GDP and SOP. Sound knowledge of laboratory equipment’s and GLP guidelines.
  • Perform calibration / verification and maintenance for laboratory equipment. Maintain and complete all my training requirements for EHS, operation, testing, equipment calibration, maintenance etc. within the required due dates.
  • To conduct On-Job training qualification programs to new analysts and Lab interns as per SOP requirements. 
  • Proactively participated in Digital Lab continuous improvement paperless QC Micro projects.

CHEMIST PHARMACEUTICALS - BioCon Solutions Pte Ltd Dec 2014 to Feb 2017 (Full-time)

Client - Amgen Manufacturing Singapore 

Responsibilities:

  • Performed routine / non-routine sampling and testing of water system and Batch related environmental monitoring (EM) according to cGMP and established procedures to support the manufacturing processes/process validation and involved in PQ of Utilities and Environmental monitoring for ASM biologics manufacturing and API facility.
  • Hands on knowledge of programming of Delta V automation system for water sampling.
  • Performed all required data entries into LIMS (Laboratory Information Management System) and cGMP documents.
  • Maintained thorough understanding of GMP and GLP regulations and have applied this knowledge to ensure proper documentation to support testing procedure. Document and review executed procedures and record data in compliance to quality system specifications.
  • Performed all required data entries into LIMS (Laboratory Information Management System) and cGMP documents.

Education

EDUCATION

  • Master of Science (M.Sc.): Medical Pharmacology, 2010 

                Dr. NTR University of Health Sciences – Andhra Pradesh, India.

  • Bachelor of Science (B.Sc.): Microbiology, Zoology and Chemistry, 2007 

               Kakatiya University – Telangana, India.

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