Priya Shukla
Senior Research Scientist
Udaipur,RJ
Summary
Dynamic M. Pharm. scholar dedicated to spearheading entrepreneurial ventures in R&D and clinical research, emphasizing innovative medical solutions that enhance global healthcare excellence. A unique blend of academic rigor and practical industry experience drives impactful advancements in the field. Passionate about revolutionizing healthcare and committed to leveraging expertise to contribute to groundbreaking developments within the pharmaceutical sector. Proven ability to navigate complex challenges and foster collaboration, ensuring successful implementation of transformative initiatives.
Overview
12
12
years of professional experience
2
2
Certifications
1
1
Language
Work History
Sr. Research Scientist (Dept.- Product Innovation)
PI Industries Ltd.
03.2024 - Current
- Involve in the execution of the Extractable and Leachable study by following USP guidelines, such as USP , USP , and ICH Q3E.
- Study of extractables by applying different extraction procedures and analytical techniques like HPLC, UPLC, LC-MS, and FTIR.
- To provide support in risk assessment following USP , along with temperature and chemical interactions.
- To support the execution of method validations and method transfers.
- Preparation, review of MDRs, test methods, method validation protocols, and reports as per requirements.
- Involve in nanoformulation activities by using the LB trough instrument.
- CFT team collaboration for data review.
Sr. Research Scientist (Dept.- MS&T)
Alembic Pharmaceuticals Ltd.
02.2020 - 03.2024
- Involve in execution of activities such as analytical method validations and transfers as per plan/schedule.
- Taking follow-up with QA/GLP team while executing the activity.
- A proactive team member with expertise in analytical method validations, transfers and stability studies, USFDA deficiency related activity, Assessment reports.
- Preparation/review of MDR, AMV, AMD, transfer and verification protocols/reports, study report/protocol, SOP, STPs and specifications as per requirements.
- Involve in CFT review of method development/validation & transfer report/protocol of vaccines, injectables and ophthalmic products.
- Involving in providing compliance for internal and external audit observations along with quality assurance department.
- Recording and maintenance of on-line documentation like logbooks, data sheets etc.
- Co-ordination for approval of all procedures, protocols and reports by the respective CFT and oversight of qualification & calibration of instruments.
- Ensure overall compliance of activities to cGMP/GLP, organization procedures and practices and effective safety systems are implemented in the premises.
Research Scientist (Dept.- ADL)
Mankind Research Centre
11.2016 - 01.2020
- Method development, validations and transfers for Injectables, Ophthalmic and Inhalation products.
- Discriminatory media selection, Development of cleaning methods.
- Expertise in analytical method development, validations, transfers and Stability studies. Mass balance study of drug products.
- Preparation & review of MDR, Test Methods, Method Validation Protocols/reports as per requirements.
- Working by following SOP, EP, USP, FDA, OECD, ICH guidelines requirements and with Strong GDP, CGMP, CGLP and USFDA related queries.
Assistant Officer (Dept.- QC-AMV)
Pure & Cure Healthcare Pvt Ltd (Subsidiary of Akums Drugs and Pharmaceuticals Ltd.)
03.2015 - 07.2016
- Execution of Method validations for Solid oral dosage forms.
- Preparation of Test Methods, AMV Protocols & Reports.
- Effectively interacts with cross functional teams to execute action items and ensure accuracy & completeness of all information.
- Ensuring compliance in the laboratory, analytical instruments and equipment’s. Analysis of Trial batches, exhibit batches and maintenance of log books and Calibration records.
R&D Chemist (Dept.- Analytical R&D)
Multani Pharmaceuticals Ltd
04.2014 - 03.2015
- Wet analysis, Routine and Stability analysis for Drug products.
- Preparation of analytical method validation reports & protocols.
Education
M. Pharma - Pharmacology
Dr. APJ Abdul Kalam Technical University (Formerly UPTU)
Lucknow12-2013
B. Pharma - Pharmacy
Dr. APJ Abdul Kalam Technical University (Formerly UPTU)
Lucknow06-2011
12th - undefined
Uttar Pradesh Technical Board
Prayagraj01.2006
10th - undefined
Uttar Pradesh Technical Board
Prayagraj01.2004
Skills
Collaboration in USFDA deficiency related activity, Assessment reports preparation CMC data review of ANDA projects for the markets US, EU and ROW
Preparation and review of AMD, AMV, AMT studies protocols, reports, MOA, Specifications, SOP and STP Preparation and review
Involved in QMS activity as Change control, Investigation and CAPA
Worked on formulations such as, Injectables, Ophthalmic, Inhalations products, Solid Orals, Drug Substances, Nano formulations and Excipient
Instruments handled as: HPLC, UPLC, LC-MS, Ion Chromatography by Empower and Chromaleon 60 Software
Electro lab Dissolution Tester, Lab India Dissolution Apparatus USP-I II (Auto Sampler) and USP-IV (Sotax–automated) Apparatus
UV-Visible Spectrophotometer; AAS; FT-IR Spectrometer;
KF auto titrator and Potentiometric Auto titrator, Rheometer, Particle size analyzer and Litesizer; Osmometer; Surface tensiometer; Viscometer; Densitometer
Langmuir Blodget Trough Instrument
Wet lab analysis, Extraction and separation technique
Worked on software such as QCMS, LMS, DCS, Lab-X and LIMS
MS Office
Certification
GPAT, 2011
Publications
- Shukla and Kumar, IJPSR, 2015; Vol. 6(1): 361-366. “Acute toxicity study of ethanolic extract of solanum lycopersicum (leaf) in Swiss albino mice”.
- Priya Shukla et al, IJCPS, 2013: Vol.1(8), 521-527. “A Review on the Taxonomy, Ethnobotany, Chemistry and Pharmacology of Solanum Lycopersicum Linn”.
- Girendra Kumar Gautam and Priya Shukla et al, IJMPR, 2014, Vol.2(1): 475-478. “Some Disease or Disorder Treated by Indian Medicinal Herbal Plants”
Internship
One Month Internship at Feezo Chem Pharmaceuticals Manufacturers, Kanpur.
Strength
- Hard Working and Sincerity.
- Self-Confident and Self Motivating.
- Practical Approach to Problems solving.
- Timely delivery of Product.
- Team management and co-operation.
Timeline
Sr. Research Scientist (Dept.- Product Innovation)
PI Industries Ltd.
03.2024 - Current
Sr. Research Scientist (Dept.- MS&T)
Alembic Pharmaceuticals Ltd.
02.2020 - 03.2024
Research Scientist (Dept.- ADL)
Mankind Research Centre
11.2016 - 01.2020
Assistant Officer (Dept.- QC-AMV)
Pure & Cure Healthcare Pvt Ltd (Subsidiary of Akums Drugs and Pharmaceuticals Ltd.)
03.2015 - 07.2016
R&D Chemist (Dept.- Analytical R&D)
Multani Pharmaceuticals Ltd
04.2014 - 03.2015
12th - undefined
Uttar Pradesh Technical Board
10th - undefined
Uttar Pradesh Technical Board
M. Pharma - Pharmacology
Dr. APJ Abdul Kalam Technical University (Formerly UPTU)
B. Pharma - Pharmacy
Dr. APJ Abdul Kalam Technical University (Formerly UPTU)