Emerging Researcher in Pharmaceutical Sciences
Resume:
RUTA PANDIT
*************@*****.***
Lake Hiawatha, NJ
SUMMARY
Proactive junior researcher with a passion for scientific discovery and a strong foundation in pharmaceutical sciences. Eager to be part of public health through compliance with international regulatory standards. Successfully coordinated laboratory projects, ensuring adherence to best practices and safety standards. Proficient in statistical analysis, regulatory and documentation management, contributing to the clarity and reproducibility of research findings. Committed to advancing health-related research through innovative methodologies and collaborative teamwork. PROFESSIONAL EXPERIENCE
Nutra-Med Packaging Inc [March 2023 – August 2023]
• Demonstrated strong attention to detail, willingness to learn and ability to work in fast paced regulated pharmaceutical environment. Collaborated with packaging teams to gain exposure to shop floor operations and quality oversight.
• Assisted in management of label lifecycle control including label issuance, reconciliation, organized documentation and destruction under supervision to prevent labeling mix -ups and ensure data integrity.
• Assisted in preparing shipper labels under supervision as per the customer requirements, ensuring correct product name, lot number, expiry date, quantity and description details. Supported review of printed shipper labels against customer approved templates and regulatory standards.
• Shadowed senior QA professionals in thorough review of packaging batch records to ensure accuracy, completeness and compliance with cGMP and internal SOPs. Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) - TATA Memorial Centre [September 2017 – December 2018]
• As a Junior research fellow in oncology Clinical trials, assisted in the design and implementation of experiments, ensuring adherence to protocols and safety regulations. Preparation and maintenance clinical trial study documents such as patient consent forms, drug related medical reports, Maintained accurate records of experimental procedures and results, contributing to the integrity of the research process (like CRF entries, Drug receipt, Pharmacokinetic sample related activities, documentation and maintenance of records like Site Master File, AE/SAE reporting, Deviations reporting, Periodical study progress report preparation and audit report preparation).
• Utilized laboratory equipments for the analysis of pharmacokinetic samples using modern bio analytical techniques like HPLC, protein assays and software tools to conduct experiments and gather data efficiently.
• Successfully coordinated with patients and medical professionals (team of doctors and nurses) about the study progress, financial reimbursements, sponsor requests, ethics committee suggestions. Worked as mediator and primary point of contact to patients and doctors, explaining complex medical conditions/ drug usage/ dosage /side effects in the simple, audience focused language.
• Coordinated with external collaborators to facilitate the exchange of information and resources for joint research initiatives. Provided technical support and troubleshooting assistance during experiments, improving overall research productivity. Maintained compliance with institutional and federal regulations concerning laboratory practices and research ethics. Colgate Palmolive India Ltd., Mumbai. [June 2016 – May 2017]
• Worked in the Implementation and Support – Personal care Products Department – India Global technology Centre (IGTC). Involved in the product making process of Bar Soaps, supporting AMEA region. Assisted in the design and execution of experimental protocols, ensuring adherence to best practices and safety standards.
• Conducted comprehensive literature reviews to support ongoing research projects and identify knowledge gaps. Analyzed and interpreted data using statistical software such as SPSS and R, contributing to the formulation of research conclusions.
• Collaborated with senior researchers and team members to prepare presentations and reports summarizing research findings. Maintained accurate and detailed records of experiments and observations to facilitate reproducibility and data integrity for projects like Color development, Raw material Qualification, supplier Qualification.
• Assisted in the management of laboratory inventory and supplies, ensuring availability of necessary materials for research activities. Contributed to the development of data visualization presentations, effectively communicating complex findings to diverse audiences.
• Participated in weekly team meetings to discuss project progress, challenges, and strategies for overcoming obstacles.
GlaxoSmithKline Pharmaceuticals, Mumbai. [July 2015 – May 2016]
• Assisted in the development and implementation of quality assurance and regulatory procedures to ensure compliance with industry standards.
• Involved in the preparation of Product Quality Documents (Finished Product Specifications, Raw Material specifications, Intermediate material specifications, Packaging material specifications) and supporting documents such as Change Controls, STP’s, Deviations, CAPA's and progress Trackers.
• Ensured timely review and approval of proposed change controls for process, facility and utility by effectively evaluating impact of changes on product quality.
• Collaborated with senior quality assurance staff to analyze data and produce quality reports for management.
• Assisted in regulatory related activities like ANDA preparation, co-ordination with R&D team for desired data, follow ups with related department for corrections and upgradation of the data, review and final submission. Assisted in drafting queries, taking annual updates from authorities.
• Worked in operational team and participated in training sessions to enhance knowledge of quality management systems and industry regulations.
• Documented findings and recommended corrective actions to address quality issues effectively.
• Engaged in root cause analysis to identify underlying quality problems and propose solutions. Supported the team in maintaining ISO certification by assisting with audits and compliance checks.
• Coordinated with production teams to ensure adherence to quality standards throughout the manufacturing process. Coordinated with Manufacturing sites for the data required for preparation of quality documents.
• Assisted in the preparation of quality training materials.
• Executed routine audits of production lines to ensure compliance with quality specifications.
• Analyzed customer feedback and complaints to identify areas for quality enhancement.
• Fostered a culture of quality awareness among team members through effective communication and training. Supported the implementation of process control measures to enhance product quality.
• Provided administrative support to the quality assurance department, streamlining documentation processes.
• Engaged in mentorship with experienced quality professionals to develop skills and knowledge in the field.
INTERNSHIP
• Worked as an intern in Liberal Pharmaceuticals, Mumbai. Received opportunity to closely observe and learn about the various sections of the industry such as solid and liquid dosage form manufacturing, packaging.
• Preparation of control document status report of quality parameters.
• Assisted in the preparation of regulatory dossiers for drug product approval according to FDA and WHO requirements.
• Assisted in archival and maintenance of dossiers in the appropriate document management systems.
• Assisting in compiling and filing of eCTD modules. EDUCATION
Pharmaceutical Sciences - Master's Degree University of Mumbai, India (2013 - 2015)
• Specialization in Pharmaceutics.
• Key subjects included - Modern Pharmaceutics, Drug Delivery systems, Regulatory Affairs. TECHNICAL EXPERTISE
• Worked as research associate and received Mumbai University Research Grant and Certificate of Appreciation for the research project at Master level for the project "Design and development of anti hyerlipidemic formulation". Various steps involved were including but not limited to - Raw Material procurement, Preliminary in vivo activity check for hypothesis, isolation and characterization for reference standard, Analytical method development for in vitro studies, Formulation and evaluation of solid dosage form, in vivo studies of the developed formulation.
• Well versed in CMC basics,international regulatory guidelines and document standards, technical writing.
• Well versed with the functioning of different departments of pharmaceutical industry namely Quality Assurance and Regulatory compliance, R&D, laboratory and clinical research, hence having thorough understanding of the cross functional areas.
ACCOMPLISHMENTS
• Published research article as an Author in JCO Global Oncology - A randomized, parallel group, open labeled, bioequivalence trial of intramuscular Pegaspargase in patients with relapsed acute lymphoblastic leukemia.
• Published review article as an Author in Indian Journal of Pharmaceutical and Biological Research - Spices and condiments : Safer option for treatment of Hyperlipidemia.
• Secured Distinction and Gold Medal in Masters of Pharmacy (GPA 8.00) CERTIFICATIONS
• Completed certificate course in Professional Diploma in clinical Research (PDCR).
• First class in Certificate for German ( Level 1) STRENGTHS
Hard and smart working, keen observer, problem solving attitude, able to work independently as well as excellent team worker, good at organizing and prioritizing tasks flexible and adaptable to change.
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