About this role
Description:
This role is responsible for managing and executing analytical R&D documentation activities to ensure accuracy, consistency, and compliance with regulatory and data integrity requirements across drug substance and drug product development. The role supports preparation, review, and lifecycle management of analytical documents including protocols, reports, specifications, and validation records. The incumbent ensures adherence to data integrity principles (ALCOA+), GLP/GMP standards, and regulatory guidelines. It drives documentation workflows, supports change control processes, and ensures timely availability of compliant documentation for development, validation, and regulatory submissions. The role collaborates with cross-functional teams to standardize documentation practices, maintain audit readiness, and enable reliable data reporting to support scientific and regulatory decision-making.
Essential Functions:
- Preparation of SOPs, Specifications, and method of analysis (Raw material, In-Process and Finished product)
- Review of DMF to prepare Analytical method and specification.
- Preparation of justification of specification and characterization report.
- Preparation of analytical reports (like Equivalency, Investigation study, Reconstitution study or dilution study, Elemental Risk Assessment Report, Nitrosamine Impurity Risk assessment)
- Preparation of Documents for form 29 Applications.
- Good understanding for Impurity profiling.
- Well versed with current agency requirement.
- Well versed with ICH quality guidelines
- Good knowledge for Pharmacopoeia
- Good communication especially writing skills for preparing quality documents and coordination with Cross functional team
Additional Responsibilities:
Education:
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
Experience:
- 5 years or more in 5 - 8 Years
Specialized Knowledge: Licenses: