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 sitesPrepare specification STPs Justification and technical reports for the assigned productsUnderstand 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 challengesAdditional 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
Key Skills
Airside Operations,Accountancy,Data Warehousing,Actuary,Import & Export,Corrosion
Experience : years
Vacancy : 1