Executive, Analytical R&D Documentation Injectable

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Ahmedabad seeks an analytical R&D documentation specialist to manage and execute documentation across drug substance and product development, ensuring data integrity and regulatory compliance.

You will prepare, review, and lifecycle manage protocols, reports, specifications, and validation records, driving documentation workflows and change control for timely regulatory submissions.

Qualifications

• 5+ years of experience in analytical R&D documentation and life-cycle management.
• Familiarity with regulatory guidelines and data integrity (ALCOA+) principles.
• Experience preparing, reviewing, and maintaining protocols, reports, specifications, and validation records.
• Strong writing skills and ability to coordinate with cross-functional teams to ensure audit readiness.

Responsibilities

• Prepare SOPs, specifications, and method of analysis documentation.
• Review DMF to support analytical methods and specifications.
• Prepare justification of specifications and characterization reports.
• Create analytical reports such as equivalency and impurity risk assessments.
• Coordinate documentation for regulatory submissions and Form 29 applications.

Skills

Documentation

ALCOA+

GLP/GMP

ICH guidelines

Pharmacopoeia

Written communication

Cross-functional collaboration

Education

B. Pharm

M. Pharm

Job description

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.

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

QUALIFICATIONS

Education

• B. Pharm B. Pharm - Required
• M. Pharm M. Pharm - Preferred

Experience:

• 5 years or more in 5 - 8 Years

Specialized Knowledge:

Licenses:

About Us

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.

About The Team

The Human Resources team partners 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.