Executive, Analytical R&D Documentation Injectable

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 700,000 - 1,200,000; Full time

Job summary

Amneal Pharmaceuticals LLC seeks a documentation-focused professional to manage analytical R&D documentation, ensuring accuracy, consistency, and regulatory compliance across drug substance and product development. You will support lifecycle management of protocols, reports, specifications, and validation records while upholding ALCOA+ data integrity and data governance.

The role partners with cross-functional teams to standardize practices, maintain audit readiness, and enable reliable data

Qualifications

• Bachelor's degree in pharmacy required; master’s degree preferred.
• Experience ensuring GLP/GMP compliance and regulatory guidance adherence.
• Strong written communication for quality documents and cross-functional coordination.

Responsibilities

• Prepare SOPs, specifications, and analytical methods for raw materials, in-process, and finished products.
• Review DMF to prepare analytical methods and specifications.
• Prepare justifications of specifications and characterization reports.
• Draft analytical reports such as equivalency studies, investigations, reconstitution studies, and impurity risk assessments.
• Prepare documents for Form 29 applications.
• Maintain impurity profiling knowledge and current agency requirements.
• Align with ICH quality guidelines and pharmacopoeia references.
• Communicate effectively in writing and coordinate with cross-functional teams.

Skills

Documentation writing

Regulatory knowledge

ALCOA+ data integrity

Cross-functional collaboration

Education

B. Pharm

M. Pharm

Job 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

Education:

• B. Pharm B. Pharm - Required

• M. Pharm M. Pharm - Preferred

Experience:

• 5 years or more in 5 - 8 Years