Y-Axis Jobs Logo
Send us feedback
telephone  +91 7670 800 001
Log in Sign up Try Premium
Analytical Specialist- Formulation AR&D at Dr Reddy's Laboratories Limited
Hyderabad, Telangana, India -
Full Time

Start Date

Immediate

Expiry Date

04 Jan, 26

Salary

0.0

Posted On

06 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Analytical Skills, Problem-Solving, Communication, Interpersonal Skills, Method Development, Technology Transfer, Regulatory Knowledge, Pharmacopeias Knowledge, Experiment Execution, Technical Report Writing, Impurity Assessment, Residue Analytical Methods, Collaboration, Critical Method Finalization, Specification Preparation, New Technology Identification

Industry

Pharmaceutical Manufacturing

Description
Job Description Analyze critical API, excipient, and FP methods in R&D, and prepare verification reports to facilitate method transfer at the manufacturing site. Core knowledge on Derma products, method development, and technology transfer is mandatory. Perform elemental, genotoxic, and nitrosamine impurity assessments. Develop and validate residue analytical methods. Prepare technical justification reports in consultation with an expert. Execute experiments to finalize critical methods and prepare method design and development reports. Identify and ensure the availability of prerequisites like columns, chemicals, impurities, and standards for AMT at partner sites Prepare specification, STPs, Justification and technical reports for the assigned products Understand regulatory requirements specific to all regulated markets. Knowledge on drafting the responses to regulatory queries. Conversant with all pharmacopeias and guidelines. Identify new technologies for project-specific challenges Additional Information Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams.
Responsibilities
Analyze critical API, excipient, and FP methods in R&D, and prepare verification reports for method transfer. Develop and validate residue analytical methods while ensuring the availability of necessary prerequisites at partner sites.