Executive, Analytical R&D Documentation Injectable

Executive, Analytical R&D Documentation Injectable

Ahmedabad City, Gujarat, India

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

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

REQUIRED SKILLS

Data Integrity & Documentation Security

Document Control & Governance

Document Review & Approval

Documentation & Record Control

Good Documentation Practices (GDP)

Record Retention & Archiving

Regulatory & Quality Documentation Control

SOP Development & Control

Technical Documentation

Version Control of Documents

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.

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JOB INFO

Job Identification

9236

Job Category

Analytical R&D

Posting Date

10/13/2026, 12:20 PM

Locations

Plot No

18, Magnet Corporate Park, Ahmedabad, Gujarat, IN

Apply Before

10/27/2026, 12:00 AM

Degree Level

Master's Degree

Job Schedule

Full time

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Plot No

18, Magnet Corporate Park, Ahmedabad, Gujarat, IN

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