Shalaka Vaidya
Eindhoven
Summary
My career aspiration in the Pharmaceutical Industry is to contribute to the development and manufacturing of innovative drugs that improve patient lives. I seek opportunities to work with dynamic teams in Clinical research, development, Regulatory and production roles to address complex healthcare challenges. By combining my scientific expertise with a commitment to excellence and compliance, I aim to play a pivotal role in advancing pharmaceutical solutions. I am committed to upholding the highest Ethical Standards and Patient Safety.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Ingenious Brandcare
Freelancing - Medical Content Developer
Ankleshwar
01.2020 - 03.2020
- Designed visual aids and LBL's of medical products for 3 companies.
- Provided marketing collaterals and technical support.
- Provided product information and use of Active ingredient.
- Promoted high customer satisfaction by resolving problems with knowledgeable and friendly service.
Executive Trainee
Lupin Research Park
Pune
09.2016 - 01.2018
- Involved in GLP practices and performing Calibration of Kf, weighing balance, pH meter (routine and monthly).
- Documentation and record keeping: detailed records of all formulation activities, including ingredients used, instrument settings, and experimental conditions. Prepared batch records and other documentation as required by regulatory agencies and prepared PDR data of various products for litigation purpose.
- Routine and stability analysis of various ER, IR tablets and capsules (dissolution testing and HPLC analysis).
- Collaborated with research and development teams to create and optimize formulations based on project requirements. Evaluating existing formulations and suggested improvements to enhance product quality and stability.
- Preparation of SOP's and specifications, Handling deviations.
- Knowledge about study documentation, including protocols, informed consent forms, and case report forms.
- Deep knowledge about Regulatory bodies, Phases of clinical trails, ICH guidelines, CSR, IB, CTD modules.(Acquired from extensive CRA course).
- Hands on training of Operations at Pilot Plant, Preclinical Pharmacology, HPLC instrument.
- Dedicated to staying current with industry trends, emerging technologies, and regulatory changes.
- Proven ability to meet project timelines, budgets, and quality standards in a fast-paced pharmaceutical environment.
- Created presentations outlining the objectives, timeline, and budget for upcoming projects.
- Participated in team brainstorming sessions to generate innovative ideas for problem-solving initiatives.
Intern Trainee
Medley Research Center
Mumbai
06.2013 - 12.2013
- Prepared small scale Formulation batch for generic drugs including Tablets, Capsules, syrups, Suspensions, etc.
- Operated a wide range of laboratory instruments and equipment required for formulation work.(Tablet/capsule machines, stirrers, blenders, homogenizers) Weighing scales and balances, High-performance liquid chromatography (HPLC) Gas chromatography (GC)Spectrophotometers, Rheometer, Particle size analyzers, Viscometers.
- Documentation and record keeping: detailed records of all formulation activities, including ingredients used, instrument settings, and experimental conditions. Prepare batch records and other documentation as required by regulatory agencies and PDR data of various products for litigation purpose .
- Experienced in adhering to Good Manufacturing Practices (GMP) and regulatory requirements in pharmaceutical manufacturing.
- Assisted in conducting research for the development of new products and services.
- Provided support to team members with project-related activities.
Education
Master of Science - Pharmaceutical Sciences
School of Pharmacy And Technology Management, NMIM
Shirpur, India05.2012
Bachelor of Science - Pharmaceutical Sciences
P.D.V.V.P.F's College of Pharmacy
Ahmednagar, India06.2008
Skills
- Clinical Research
- ICH guidelines
- Drug Regulatory
- Pharmacokinetics
- Quality Control, Quality Assurance
- GMP, GLP
- Medical writing
- Regulatory Documentation
- SOP, Litigation
- QbD tool
- Written and Verbal Communication
- Analytical and Critical Thinking
- Problem Resolution
- Team Management
- Software Proficiency (MS word/Excel/ppt)
Languages
English, Marathi
First Language
German
Intermediate
B1
Accomplishments
- GPAT qualified (2016) - all India Rank 1436
- PUBLICATION: “Formulation, Optimization and Evaluation of Gastro Retentive Floating Microspheres of Pregabalin“, Asian Journal of Biochemical and Pharmaceutical Research Issue 3 (Vol. 4) 2014.
- Participated in “YICC” 2012, Institute of Chemical Technology, Mumbai. 1st prize in Manshodhan 2012 (National level research competition). Participated in “Avishkar 2010”, Zonal level Research Project Competition.
- Workshops: Attended workshop of 7 weekends on Intellectual Property rights Fundamentals” 2013 IIT Mumbai.
- Key note speaker at (Immaculate High Impact Technical Presentation) Conducted by IEEE, NMIMS Shirpur 2013.
Certification
- Certified : Clinical Research Associate. Viares Academy (01/2022- 05/2022): 87.13% (Vienna, Austria).
- Medical Writing for Health care Professionals. Udemy: 01/2022.
- Improving Your Leadership Communications: LinkedIn: 07/2023.
- Communicating with Emotional Intelligence: LinkedIn: 07/2023.
Personal Projects
- Six months internship in Medley research center in department of Research and Development (06/2013-12/2013: Formulation, Development and Evaluation of Fixed Dose Combination containing Digestive Enzyme, Anti-Flatulent and Anti-Emetic Durg for immediate release dosage form using Extrusion and Spheronization.
- Four month Minor Project in Institution Laboratory (01/2014- 05/2014): Formulation and Evaluation of Gastro Retentive Floating Microspheres of Pregabalin using Quality by Design Approach (QbD).
Timeline
Ingenious Brandcare
Freelancing - Medical Content Developer
01.2020 - 03.2020
Executive Trainee
Lupin Research Park
09.2016 - 01.2018
Intern Trainee
Medley Research Center
06.2013 - 12.2013
Master of Science - Pharmaceutical Sciences
School of Pharmacy And Technology Management, NMIM
Bachelor of Science - Pharmaceutical Sciences
P.D.V.V.P.F's College of Pharmacy
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