Analytical Specialist- Formulation AR&D
Analytical Specialist- Formulation AR&D
Posted on :
07-10-2025
Employer Active
1 Vacancy
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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.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
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