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Cdymax India Pharma
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Senior Executive - Analytical Research & Development

Senior Executive - Analytical Research & Development

Cdymax India Pharma

7 - 10 years

6 - 8 Lacs

bengaluru

Posted:1 day ago| Platform:

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Skills Required

analytical method development method validation method transfer

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Key Result Areas (KRA) Senior Executive (Analytical Development)

API Method Development

Develop, optimize, and troubleshoot analytical methods for APIs using
HPLC and GC techniques
.
Perform
Related Substances and Assay method development
in compliance with regulatory guidelines.

Related Substances Method Development

Independently develop and document a minimum of
20 Related Substances analytical methods
for API projects.
Ensure robustness, specificity, accuracy, and precision of developed methods.

Method Validation Expertise

Execute and review
method validation
for Related Substances and Assay methods as per
ICH and regulatory requirements
.
Prepare and compile validation protocols, reports, and analytical documentation.

Project Ownership & Execution

Independently handle
analytical development projects
from method development to validation and transfer.
Coordinate with cross-functional teams to ensure timely project completion.

Documentation & Compliance

Maintain complete and accurate analytical records in line with
GLP and data integrity
standards.
Support regulatory submissions by providing analytical data and justifications when required.

Preferred - Male Candidate

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