Vani Shree
Mangalore
Summary
Experienced Quality (Assurance & Control) Specialist skilled at managing laboratory activities and audits with a solid record of achievement over 06 years of experience in Quality & Pharmaceutical environments(GxP). Top-notch abilities in facilitating communication, planning projects and solving operational problems. Familiar with the unique standards and compliance requirements in the pharmaceutical industry.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Quality Assurance Analyst
Lotus Labs Private Limited (Client: Teva Pharmaceuticals)
Bangalore
02.2023 - Current
- Responsible for Performing data analysis and validation of pharmaceuticals to ensure compliance with regulatory standards.
- Responsible for review and approval of Non-conformities like OOS, OOT, OOC, and Incidents.
- Responsible for review and approval of Deviations, Risk assessment and change control management.
- Responsible for Preparation of Audit response.
- Responsible for System Audit to analyze the efficacy of pharmaceutical products.
- Responsible for verifying the test results to identify potential issues with drug formulations or production methods.
- Responsible for developing SOPs related to analytical testing procedures for new drugs and products.
- Responsible for Investigating customer complaints concerning product quality issues or discrepancies between batches.
- Responsible for Verifying functionality and accurate calibration of laboratory equipment, spectrometers and chromatographs.
- Authorized to make decisions and execute changes based on process data, quality checks and test results to keep products at target and within specifications.
- Review and monitoring the quality assurance reports for accuracy and completeness.
- Responsible for Conducting internal audits of production processes to identify areas of improvement in product quality.
- Responsible for Investigating customer complaints related to product quality, identified root causes, and recommended corrective actions.
- Responsible for Identifying potential non-conformances during the development process and implemented corrective action plans.
- To Provide guidance on best practices in quality assurance techniques to other departments within the organization.
- Responsible for Creating detailed documentation of audit findings, including recommendations for resolution of any issues identified.
- Responsible for Coordinating with cross-functional teams in order to develop quality management systems that meet industry standards.
- Responsible for Developing training materials related to Quality Assurance Auditing procedures.
- Responsible for Planning and performing Monthly and periodic of GLP laboratory.
- Responsible for improving the standard process measurement reporting using Audit findings.
- Sought opportunities for professional development and training to achieve professional certification.
- Learned new testing methods through continued education and research.
Research Associate
Baxter global research center at Syngene international limited
Bangalore
03.2020 - Current
- Provided qualified input and development support for analytical plans and study protocols
- Analytical Method development and validation of methods by HPLC, UPLC, UHPLC and Potentiometry for raw material and injectables
- QC Review of documents of method transfer study by UPLC, HPLC and Potentiometry
- Method transfer and validation of analytical methods
- Have good technical skills on HPLC, UPLC, UHPLC and Potentiometry
- Good knowledge on Agilent GC with empower software
- Worked on Karl Fischer titrator (KF) for water content determination of raw material
- Provided support as needed in calibration and maintenance of equipment in the laboratory
- Calibration of HPLC, UPLC, UHPLC, Analytical balance and pH meter
- Performed feasibility and verification studies for compendial studies as per EP monograph
- Preparation of protocol and reports
- Followed good documentation practice (GDP) and Good manufacturing practice (GMP)
- Good knowledge on ALCOA+ principles, QMS, change control, deviation and CAPA
- Created plans and communicated deadlines to complete projects on time
- Willing to work in a fast-paced environment with demonstrated capacity to handle multiple tasks and demands
- Learned new skills and applied to daily tasks to improve efficiency and productivity
- Used coordination and planning skills to achieve results according to schedule
- Good practice on Kaizen and 6S, ICH, FDA, 21CFR.
Research scientist
Eurofins Advinus
Bangalore
05.2018 - 02.2020
- Analysis of dose formulation received from toxicology and pharmacology department to support clinical trials under good laboratory practice
- Analytical method development and validation of method by HPLC, UPLC, UHPLC for drug suspensions
- Calibration of HPLC, UPLC, UHPLC, Weighing balance, pH meter, Micropipettes
- Preparation and review of report and study plans
- Followed Good Laboratory practice (GLP) and Good documentation practice (GDP).
Education
M.Pharm - Pharmaceutics
Manipal College of Pharmaceutical Sciences - Manipal
03.2018
B. Pharm - Pharmacy
Sridevi College of Pharmacy - Mangalore
06.2016
Skills
- Good Laboratory Practices (GLP)
- Good Manufacturing Practices (GMP)
- Good Documentation Practices (GDP)
- ALCOA
- Method validation
- Very Good knowledge on CAPA
- Chromatography Techniques
- HPLC Operation
- HPLC Trouble shooting
- GC-MS Knowledge
- Chromatography Expertise
- Troubleshooting Techniques
- Calibration skills
- Instrument Calibration
- Pharmaceutical industry knowledge
- Good presentation and communication skills
- Excellent Documentation expertise
- Excellent Presentation management
- Excellent time management abilities
- Excellent Problem-solving proficiency
Specialization
Master of Pharmaceutical Sciences (Pharmaceutics, Analysis, Regulatory)
OBJECTIVE
To build a long-term career in Healthcare & Pharmaceuticals sector with opportunities for career growth by using my skillset in the best feasible way.
Additional Information
9.5 months academic project internship at Baxter global research center at syngene Bangalore 2017-2018, M Pharm Thesis: Method development and Validation of cysteine in nutrient formulation by Liquid chromatography
DECLARATION
I hereby declare that the details mentioned above are accurate to my knowledge.
VANISHREE
INSTRUMENTATION
- HPLC, UPLC, UHPLC (Empower, Chromelion)
- GC-MS (Mass Hunter)
- LC-MS (Empower)
- Titration (Tiamo)
- Potentiometer (Tiamo)
CERTIFICATE
TRACKWISE
Empower 3
Glorya
Studium
Languages
Kannada
First Language
English
Advanced (C1)
C1
Hindi
Upper Intermediate (B2)
B2
Certification
- Licensed Pharmacist certificate
- Certificated on Pharma Drug Regulatory Affairs course-DRA 2022 from UDEMY
Accomplishments
Awarded from Rajiv Gandhi University of health sciences.
- 8th rank in pharmacology
- 7th Rank in Pharma engineering
- 10th rank in Human anatomy and physiology
Timeline
Quality Assurance Analyst
Lotus Labs Private Limited (Client: Teva Pharmaceuticals)
02.2023 - Current
Research Associate
Baxter global research center at Syngene international limited
03.2020 - Current
Research scientist
Eurofins Advinus
05.2018 - 02.2020
M.Pharm - Pharmaceutics
Manipal College of Pharmaceutical Sciences - Manipal
B. Pharm - Pharmacy
Sridevi College of Pharmacy - Mangalore
- Licensed Pharmacist certificate
- Certificated on Pharma Drug Regulatory Affairs course-DRA 2022 from UDEMY
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