Executive Analytical RandD Documentation Injectable

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a proactive analytical R&D documentation professional to manage and execute documentation activities across drug substance and drug product development. You will ensure data integrity, GLP/GMP compliance, and timely, audit-ready documentation for development, validation, and regulatory submissions.

Responsibilities include SOP/specifications/method preparation, DMF reviews, and analytical report generation while aligning with cross-functional teams to

Qualifications

• B.Pharm is required.
• 5+ years, analytical documentation in pharma sector.
• Experience with regulatory submissions and validation records.

Responsibilities

• Prepare SOPs, specifications, and method of analysis for materials and products.
• Review DMF to prepare analytical method & specification.
• Prepare justification of specification and characterization reports.
• Prepare analytical reports (equivalency, investigation, reconstitution, nitrogen risk assessment).
• Prepare documents for Form 29 applications.
• Ensure adherence to ICH guidelines and current agency requirements.

Skills

ALCOA+ data integrity

Regulatory compliance

Documentation management

Communication/writing

GMP/GLP knowledge

Education

B.Pharm

M.Pharm

Tools

MS Office

Document management systems

Job description

Job Description:

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

Qualifications

Education:

• B. Pharm B. Pharm - Required

• M. Pharm M. Pharm - Preferred

Experience:

• 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

TheHuman Resources teampartners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key roles that the Human Resources team performs:

Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.

Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.

Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.

Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.

Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.

Requirements: