PRAGNYA NIDHI SABBINENI

Hyderabad | C: +919059028659 | pragnyanidhi95@gmail.com | https://www.linkedin.com/in/PragnyaS

Professional Experience

Summary

▪ Over 5years experience in pharmaceutical, biotech, drug manufacturing industry with software Development
life cycle 21 CFR part-11 Validation, Change control management testing, Quality management system and
implementation of business applications.
▪ Followed Standard Operating Procedures (SOPs), protocols and other instructions from management to
perform release testing for raw materials and finished products, validate analytical methods, and qualify
analytical instruments.
▪ Developed a whole software development life cycle, completed whole phase of Impact assessments, helped
build SOPS, forms according to GAMP requirements for gap assessments and risk assessments.
▪ Spearheaded diverse projects for data capture, storage, configuration and forecast analysis, performed, and
helped analysts in validations/tech transfers of new test methods.
▪ Review and approval of equipment qualification / calibration/ validation reports associated with reference
standards development and evaluation. Additionally, review and approval of in-house equipment qualification
protocols.
▪ Performed QA review on protein characterization utilizing variety of analytical tools, especially HPLC, GC
and ICP-MS.
▪ Hands-on experience with LCMS & Equipment Software, LIMS, SAP, Track wise.
▪ Prepared well written and organized development reports to convey the quality of the methods to clients
▪ Knowledge of USP, EP, FDA, and ICH requirements as they apply to production of drug substances and drug
products.
▪ Performed data evaluation and analyses including deriving frequencies, lists data subsets and descriptive
statistics such as means, graphs and charts, developing statistical models and conducting significance testing.
Wrote original software programs required to perform the data and manipulation and analysis.
▪ Spearheaded COVID-19 outbreak investigations.
▪ Implemented CDC and OSHA driven infection prevention and control policies to guide on-site departments

DKR labs, Compliance specialist, India May

2022-Still

 Worked with Analytical team in writing SOPS, maintaining standards, policies, guidelines, processes and
manage to ensure no risk.
 Support the Audit team in drafting audit reports and comments, following customer request evaluation of
CAPA plan.
 Review and approval of equipment qualification / calibration/ validation reports associated with reference
standards development and evaluation. Additionally, review and approval of in-house equipment
qualification protocols.
 Reviewed and approved quality notifications such as deviation, OOS/OOT, Issue(incident), change control,
and corrective and preventive action.
  Coordinated with Cross Functional Team on investigation, RCA, CAPA and timely closure of quality
notifications.
 Developed training and trained new employees with QA orientation, applicable in-house procedures, Quality
topics QA orientation and six sigma procedures.

Wuxi AppTec, QA Computer systems specialist Philadelphia, USA Nov 2020-

Nov 2021

 Review and approval of equipment and facility validations including the IQ, OQ, PQ and computer software
validation.
 Support the implementation of fully GxP compliant Computer Systems Validation Lifecycle program in
direct correlation with the Site Quality Management System (QMS);
 Successfully lead team B of the new lifecycle program including (at a minimum) a GAMP5 Risk Based
Approach Validation program and 21 CFR Part 11 requirements that regulated companies must minimally
follow to achieve the level of integrity, reliability, and consistency of electronic records and signatures
acceptable to the FDA and EU by Aug 2021.
 Reviewed Periodic Reviews, Performed Periodic Reviews, helped converting them from paper to electronic
in BRAM.
 Developed a whole software development life cycle, completed whole phase of Impact assessments, helped
build SOPS, forms according to GAMP requirements for gap assessments and risk assessments.
 Helped in URFS for different instruments like Protein ELLA, NC-200, Protein analyzer.
 Managed the qualification or the validation (as applicable) of laboratory information systems and LabX.
 Review of manufacturing Batch records and QC batch testing reports for compliance to cGMP and product
licenses, achieving > 90% monthly shipping targets.
 Access and review site deviations for content and completeness and collaborated daily with multi-functional
teams to drive on time target achievements
 Managed a number of key projects to improve cycle time, eliminate and improve batch record review
processes focused on meeting customer business requirements.
 Responsible for authoring External Customer complaint Investigations
 Participated to the qualification of third-party vendors as their service pertains to information systems.
 Reviewed and approved Out of Tolerance (OOT) investigations. Reduced backlog to less than 25%.

Johnson & Johnson, QA Specialist, Malvern USA May 2019-

Nov 2020

 Supported laboratory risk management program as it pertains to information systems.

 Managed the validation and upgrades of internal LIMS and LabX.
 Created/compiled the documentation associated with the development, deployment, and maintenance of
compliance with FDA regulations.
 Performed supplemental research to provide options for compliant solutions to barriers encountered during
validation activities.
 Worked with QA, IT and Lab Ops teams to ensure that data integrity principles are considered during the
requirements and design phase of new projects.
  Participated in data integrity and data governance program.
 Worked with IT team to maintain the catalog of GxP relevant software systems.
 Participated in customer and audits as software QA subject matter expert.
 Participated in audit close-out meetings and audit Findings/responses are applicable
 Establishing effective corrective and Preventive actions (CAPA) along with thorough Investigations to
reduce complaints.
 Aided in the Supplier Management/Qualification process, including compiling paper audits of suppliers and
ensuring adherence to the Supplier Qualification Program.
 Communicated with vendors to obtain Quality Agreements.
 Work with QA Raw Materials and Procurement to establish vendor history files.
 Updated the Approved Supplier list (ASL).
 Reviewed and approved IQ/OQ/PQ of equipment (Temperature Controlled Units)

Sun pharma New Brunswick NJ, Quality Assurance Specialist, New Jersey USA Jun2018-
May2019

 Prepared and maintained tracking/testing systems, (i.e., LIMS, SAP Logbooks, OCR, Web scan, etc.) which
are used for testing and to reflect the status of samples. Reported status to appropriate laboratory,
manufacturing and planning groups at pre-determined intervals. Applies technical principles, concepts and
understanding of systems (SAP and Track Wise) as well as proficiency in Excel and Word.
 Reviewed, Approved validation/Qualification/verification protocols and reports associated with new product
or material entry.
 Reviewed and approved LIMS and LES changes
 Helped maintaining site practices and procedures related to laboratory instrument qualification, usage, and
method execution and trending, ensuring compliance with regulatory expectations
 Worked with area management on the writing, issuance and tracking of deviations and investigations for
closure.
 Performed and assist with GMP audits.
 Evaluated performance of instrumentation and validity of test results
 Have profound knowledge of the FDA, EP, JP about Computer Systems.

DKR Pharma Limited, Working Experience, (Quality Assurance Associate), India Jun 2013-
Jul 2015

 Reviewed and approved Standard Operating Procedures, Specifications, Deviation Reports, Change Controls,
and supporting documentation.
 Reviewed and approved the data for determining the disposition of GMP material (raw material, in-process,
finished product, packaging, labeling and manufacturing components) and the review and approval of
documents and data associated with the Stability Program.
 Initiated and participated in investigations (including Laboratory Investigations).
 Managed the CAPA process including initiation, closure and performance of Effectiveness Checks.
 Reviewed and approved batch records for release of customer product.
 Resolved any documentation discrepancies related to assigned tasks.
 Updated paper and electronic records.
 Areas of Expertise

MS Office: PowerPoint, Excel, Word, Outlook ,Title 21 code of federal regulation 21 CFR, Equipment, critical
systems , Microbial testing, USP/NF, EP/BP, JP, ACS, Biochemistry, manufacturing, Facilities, New Drug
Application (NDA), Analytical techniques Analytical techniques.
Key Competencies
Analysis and chemistry: Utilization of systematic approach to analytical methods, and their effectiveness and
efficiency. Aware of analysis, drugs and their chemistry and their structural activity relation.
Pharmaceutical engineering: knowledge of formulation, granulation, validation.
Regulatory Affairs for Drugs, Biologics and Medical Devices: A deep understanding of the USFDA rules,
regulations and guidance documents, GLP, GCP, GMP, informed consent documentation, clinical trial study
designs and various FDA forms:1571, 1572, 365h.
Certifications: certified as Quality engineer from Johnson & Johnson Company, White belt, six sigma, Lean.

Academic Projects

Impurity profiling (MS Project) under Regina Wachenheim Oct 2017-Dec 2017
• Worked on a case study and developed an appropriate project charter and constructed a complete analysis of basic
drugs.
• Worked on various samples and compared the impurities and their levels in drugs and tested different raw
materials using the analytical instrumentation.
• Described gas chromatography, HPLC and spectroscopy by using MS Project.
Co-excipients and novel drugs project (bachelor project) Sep 2015-Jul 2016
• Evaluated and analyzed various characteristics of an Excipients and Co-excipients, which included detail research
on substantial equivalence, biocompatibility studies, performance testing, labelling and packaging.
• Presented a due diligence project including variables like excipient description, non-clinical and clinical data,
substantial equivalency, adverse events, value proposition of different excipients and justification on why these
Excipients would be considered a valuable asset and acquired by another company.
X-ray diffraction (project)under Soman Mitra March2018-April2018
• Worked on machinery Of X-ray diffraction.
• Performed three different samples with help of professor using XRD.
• Prepared change final status report and summary, and complete report on machinery, different detectors used and
how samples can be tested and how it used in industries was been reported.

Education

New Jersey Institute of Technology

Degree: Master of Science: Pharmaceutical Sciences, Graduated 2018
Concentration: Chemistry, Analysis, Regulatory Affairs for Drugs, Computation modelling
Relevant Courses: Analytical chemistry, advanced analytical chemistry, validation, Regulatory of drugs and medical
devices, environmental analysis, legal aspects of environmental sciences, advanced organic chemistry,
pharmaceutical chemistry, biochemistry, molecular modelling, pharmaceutical engineering.
Gokaraju Rangaraju College of Pharmacy, Telangana, India.
Degree: Bachelor’s in pharmacy June2012-May 2016