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Aishwarya Angre - Fresher Bioanalytical Science

Aishwarya Angre is a recent graduate with a Master of Science in Bioanalytical Science, experienced in regulatory compliance within the pharmaceutical sector, particularly in clinical trials and adherence to ICH-GCP and cGMP standards. She has hands-on experience in quality control and clinical trial management, with proficiency in advanced analytical techniques and documentation. Aishwarya has also completed multiple certifications related to clinical practices and has actively participated in research and volunteer activities.

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46 views2 pages

Aishwarya Angre - Fresher Bioanalytical Science

Aishwarya Angre is a recent graduate with a Master of Science in Bioanalytical Science, experienced in regulatory compliance within the pharmaceutical sector, particularly in clinical trials and adherence to ICH-GCP and cGMP standards. She has hands-on experience in quality control and clinical trial management, with proficiency in advanced analytical techniques and documentation. Aishwarya has also completed multiple certifications related to clinical practices and has actively participated in research and volunteer activities.

Uploaded by

tiwariabhishekofficial
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AISHWARYA ANGRE

Mumbai | aishuangre18@gmail.com | +918976124465


https://www.linkedin.com/in/aishwarya-angre-2a1581236

SUMMARY

Recent graduate with a Master of Science in Bioanalytical Science, Experienced in regulatory compliance
within the pharmaceutical sector, with a focus on clinical trials, BA/BE studies, and adherence to ICH-GCP
and cGMP standards. Proficient in advanced analytical techniques, precise documentation, and ensuring
quality assurance in alignment with local and global regulatory frameworks. Skilled in maintaining
regulatory standards for nutraceuticals, cosmeceuticals, and pharmaceutical products has equipped me with
the knowledge to ensure trial protocols and clinical data meet all regulatory standards, supporting smooth
approval processes and adherence to industry guidelines.

SKILLS

 Clinical Trial Management- Clinical Trial Management, Project Management, Protocol


Development and Review, Patient Recruitment and Monitoring, Regulatory Compliance and
Documentation,GLP, ICH-GCP, FDA regulations, GMP and local regulatory guidelines.
 Documentation - EDC (electronic data capture), CRF, ICF, TMF, sample forms, checklists, and
logs of a clinical study
 Instrumental Handling – HPLC, GC, UV Spectrometer, FTIR, Karl Fischer, Dissolution
 Laboratory Techniques - Method Development and Validation, HPTLC, HPLC, GC, GCMS,
SDS-PAGE, PCR, Recombinant DNA
 Soft Skills- Excellent communication, empathy & team collaboration, Strong verbal and written
communications, Ability to manage tasks and work under pressure.

QUALIFICATION

• Master of Science in Bio analytical Science | Grade - A Aug 2022- Apr 2024
Ramnarain Ruia College
• Diploma in Regulatory Affairs | Grade - O Jun 2022- July 2023
Ramniranjhan Jhunjunwala College
• Bachelors of Science in Pharmaceutical Analytical Science | Grade – A+ Jun 2019 - Apr 2022
Ramnarain Ruia College

WORK EXPERIENCE

Quality Control Intern May 2023 - Aug 2023


Naprod Life science Pvt Ltd (Palghar)
 Observed and assisted in the testing of over 200 raw materials, intermediates, and finished
pharmaceutical products using advanced analytical techniques such as HPLC (High-Performance
Liquid Chromatography), GC (Gas Chromatography), dissolution testing, and spectrophotometry.
 Ensured compliance with current Good Manufacturing Practices (cGMP) during all testing
procedures, maintaining a high standard of quality control.
 Performed daily calibration and maintenance on 10+ critical laboratory instruments, achieving
100% operational readiness and minimizing equipment downtime.
 Monitored and documented testing data with a 100% accuracy rate, facilitating timely reporting for
regulatory compliance and contributing to successful inspections by health authorities.

Volunteer | Clinical Trial Associate May 2020 – May 2022


Institute for Advance Training & Research( TDM LAB)

 Engaged in Bioavailability/Bioequivalence (BA/BE) studies, as well as nutraceutical and


cosmeceutical trials, contributing to the design, execution, and evaluation phases of the studies.
 Implemented and monitored clinical trials to ensure that both sponsor and investigator obligations
were met, maintaining high standards of trial conduct and integrity.
 Ensured compliance with ICH-GCP guidelines and local regulatory requirements for clinical trials
directly contributing to the successful completion of 5 major studies without any reported deviations
or violations.
 Directed daily project meetings with trial teams, enforcing strict adherence to timelines and
documentation standards, enabling completion of 5 clinical studies while maintaining compliance
with regulatory requirements.

CERTIFICATIONS

 Good Clinical Practice (July 2024)


 Design and interpretation of Clinical Trials (May 2024)
 Introduction to Clinical Data (Mar 2024)
 Quality Control Chemist (Mar 2022)
 Quality Assurance Chemist (Mar 2022)
 Leading Healthcare Quality and Safety (Mar 2021)

ACTIVITIES

 Participated in college departmental fest.


 Volunteered to enhance team efficiency by organizing documentation, ensuring FDA and GCP
compliance, and maintaining regulatory standards during clinical trials and lab activities.
 Presented research work in AVISHKAR RESEARCH CONVENTION (2021-2022).
 Attended several seminars from Indian Society for Clinical Research (ISCR).

LANGAUGES

Marathi, Hindi, English

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