Senior Officer/ Executive -ARD-Rubicon Research

Rubicon Research

5 - 8 years

5 - 7 Lacs

thane

Posted:1 day ago| Platform:

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Skills Required

analytical development assay related substance dissolution method development adl relatable sus

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Provide scientific justifications or perform analytical experiments (like Assay, RS, dissolution etc) to support regulatory responses.
Collaborate with cross-functional teams (QA, RA, QC, Formulation, etc.) to address deficiencies.
Investigate and troubleshoot analytical method issues cited in regulatory feedback.
Support the development or refinement of analytical methods to meet ICH and pharmacopeial requirements.
Execute experiments related to Assay, Organic impurities, Dissolution etc by HPLC or UV.
Ensure data integrity and compliance with regulatory standards.
Online logbooks, data and LNB entries and follow GMP / GLP practices.
Read technical papers, research articles, new guidelines and participate in internal scientific discussions.
Perform calibration of instruments as per schedule.
Providing technical inputs for troubleshooting, resolving issues, etc.
Preparation of study related protocols and reports.
Participate effectively in investigations related to deviations/incidences and to suggest CAPA.

Preferred candidate profile

IMMEDILATE JOINERS or Candidate with less notice period are preferable.

Interetsed candidates may apply on madhura.patil@rubicon.co.in

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