Aishwarya R K

Aishwarya R K Email and Phone Number

||Pharmaceutical industry ||quality assurance specialist||Quality management system||LIMS||Standard operating ||SAP-LIMS||Analytical||cGMP||pharmacopoeia||CMO||R&D||CAPA||change controlICH guidelines||||Regulatory||
Aishwarya R K's Location
Bengaluru, Karnataka, India, India
About Aishwarya R K

It's been an amazing journey for me over the past few years through out my profession. As a result of these days, I've been developing different skills, especially communication between new people.As a member of the health/pharma industry, I know how much hospitality should be shown about a product going to market. It was my experience during my academic or career years that verifying/studying all the guidelines, pharmacopoeia, and further regulatory standards were crucial for ensuring quality output. After spending 3.9 years in the pharma industry, I have learned to acquire knowledge further and accept various challenges in order to become a confident individual. Moreover, I found myself that i am a kind of eligible candidate to handle my assigned projects independently with my own responsibility to complete within a deadline and I could find myself solution in case a questions raised from a team/external person in my own authorized work.Throughout my experience, I had developed my knowledge in analytical, instrumental, quality standards, ICH guideline, pharmacopoeia and further more relatable field in a pharma. I am still enthusiastic to learn more about industry. Henceforth, I took certificate course in project management. In addition, i am looking and started some other courses where i need to be best in carrier life and expecting much growth in work life.I am hardworking, very well known about importance of projects thereby according to demands of customer i know how to priorities my activity as per time scheduled. Within a short period, I learned couple of matters in a professional mode.During my academic, i utilized my opportunity to represent me in a Indian pharmaceutical congress by presenting a poster presentation based on my project work. This made me learn how to interact with external and to be confident to present my work. Currently, I am seeking an opportunity to develop furthermore skills and growth in my professional life.

Aishwarya R K's Current Company Details

||Pharmaceutical industry ||quality assurance specialist||Quality management system||LIMS||Standard operating ||SAP-LIMS||Analytical||cGMP||pharmacopoeia||CMO||R&D||CAPA||change controlICH guidelines||||Regulatory||
Aishwarya R K Work Experience Details
  • Strides
    Executive
    Strides Sep 2021 - Jun 2023
    Bengaluru, Karnataka, India
     Preparation, review and approval of Specification, Standard test procedures and Raw data sheet for drug substances, excipients and drug products in Manual and LIMS application and releasing the Master documents in LIMS (Lab ware, Ver- 07).• Initiation and daily tracking of QMS events such as Change control, CAPA and deviation through Track wise application.• Handling of SAP/LIMS queries. • Review and approval of analytical method validation/method transfer/ evaluation reports.• Supporting Contract manufacturing organisation (CMO) projects as per company as well as external requirements. • Supporting the sites during healthcare authority inspections.
  • Recipharm
    Junior Executive Manufacturing Science And Technology
    Recipharm Mar 2021 - Aug 2021
    Bangalore Urban, Karnataka, India
    Technology transfer- Quality assurance Initiation and tracking of Quality managment system activity like change control, capa, deviation and errata. Closing all QMS activity.preparation of SOPs and maintained respective registerspreparation of request for quotation for products
  • Strides
    Executive Trainee
    Strides Sep 2019 - Mar 2021
    Bengaluru, Karnataka
    .Preparation of Specification, Standard test procedures and Raw data sheetfor drug substances, excipients, and drug products.• Preparation of Residual solvent justification report (ICH Q3C) and Elemental impurity risk assessment report (ICH Q3D) for regulatory submission.• Reviewing the Drug master file in PLM software and preparing and finalising the comparison reports.• Preparation of dossier in CTD module and manage post approval changes.• Tracking the QMS events such as Change control, CAPA and deviation reports through Track wise application and implementing changes.• Collaborate with internal departments to gather necessary documentation and data for regulatory submissions.

Aishwarya R K Education Details

Frequently Asked Questions about Aishwarya R K

What is Aishwarya R K's role at the current company?

Aishwarya R K's current role is ||Pharmaceutical industry ||quality assurance specialist||Quality management system||LIMS||Standard operating ||SAP-LIMS||Analytical||cGMP||pharmacopoeia||CMO||R&D||CAPA||change controlICH guidelines||||Regulatory||.

What schools did Aishwarya R K attend?

Aishwarya R K attended Rajiv Gandhi University Of Health Sciences, Rajiv Gandhi University Of Health Sciences.

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