Akanksha Shukla
Mirzapur,Mirzapur
Summary
Dynamic R&D professional with expertise in GMP compliance and HPLC analysis, honed at Biovonic Healthcare Pvt Ltd. Proven track record in maintaining audit-ready documentation and leading cross-functional teams. Strong attention to detail and problem-solving skills drive successful outcomes in biologics characterization and quality management systems.
Overview
2
2
years of professional experience
Work History
Officer– R&D Documentation
Biovonic healthcare pvt ltd
04.2026 - Current
- Prepared and controlled R&D documents (SOPs, STPs, MFR, PDR, BMR, Protocols and reports)
- Ensured compliance with GMP, GLP, and data integrity (ALCOA+) standards to support quality assurance.
- Maintained documentation to ensure audit readiness and meet regulatory inspection requirements.
- Assisted in documenting formulation processes and procedures to enhance clarity and reproducibility.
Officer – Analytical Development Laboratory (Biologics)
Kwality Pharmaceuticals Ltd.
Amritsar
09.2024 - 03.2026
- Supported analytical method validation and stability studies for biologics.
- Performed HPLC analysis for drug formulations, ensuring accuracy and regulatory compliance.
- Conducted protein characterization using UV Spectrophotometry and SDS-PAGE.
- Developed and reviewed SOPs, STPs, COAs, and analytical reports, adhering to GMP standards.
- Oversaw QMS documentation (CAPA, Change Control), maintaining data integrity (ALCOA+).
Education
M.Sc. (Hons.) - Microbiology
Lovely Professional University
Punjab01-2025
B.Sc. - Zoology, Botany
Mahatma Gandhi Kashi Vidyapith
Varanasi01-2021
Intermediate -
Shraddha Intermediate College
Varanasi01-2018
Matriculation -
Shraddha Intermediate College
Varanasi01-2016
Skills
- HPLC analysis
- Analytical Method Validation
- Laboratory Techniques: PCR, Chromatography (HPLC), Electrophoresis, ELISA, Gram Staining, Microbial Isolation, Aseptic Techniques
- Instrumentation & Tools: Analytical Method Development, Biosafety Cabinet
- Compliance: GMP, GLP, Quality Control Procedures
- Quality Management System
- Data Quality Assurance
- Technical Document Control
- Regulatory Compliance Communication
- Quality Assurance Focus
- Process Improvement Techniques
- Cross-Functional Collaboration
- Interdepartmental Collaboration
- Software: MS Word, MS Excel, Office Tools
- Interdepartmental Collaboration
PROJECTS
- M.Sc. Dissertation Project, July 2024
- Title: Recent advancements and future prospects of endophytic promising source of Anticancer agents.
Accomplishments
- Association of Microbiologists of India- LPU unit 12/2023
- Participated in an international conference on "Microbial Bioprospecting Towards Sustainable Development Goals" held on 24-25th Nov 2
- Presented on "Mid-Gut Microbiota" at the international conference.
CERTIFICATIONS
- International Conference, ICMB '2023
- Participation – Certificate -2023
- Volunteer – Certificate-2023
EXTRACURRICULAR ACTIVITIES
- Member, Hospitality Committee, International Conference, LPU (Nov 2023).
- Active member of Microbial Mavens (Association of LPU).
Timeline
Officer– R&D Documentation
Biovonic healthcare pvt ltd
04.2026 - Current
Officer – Analytical Development Laboratory (Biologics)
Kwality Pharmaceuticals Ltd.
09.2024 - 03.2026
M.Sc. (Hons.) - Microbiology
Lovely Professional University
B.Sc. - Zoology, Botany
Mahatma Gandhi Kashi Vidyapith
Intermediate -
Shraddha Intermediate College
Matriculation -
Shraddha Intermediate College