Job Title: Executive – Analytical R&D Documentation (Injectables)
Location: Ahmedabad City, Gujarat, India
Employment Type: Full-Time
Experience Required: 4–7 Years
Job Category: Analytical R&D | Injectable Formulations
We are seeking an experienced Executive – Analytical R&D Documentation (Injectables) to support analytical documentation activities within a regulated pharmaceutical manufacturing environment. This role is critical for ensuring compliance with global regulatory standards through accurate, high-quality documentation related to injectable products. The position requires strong expertise in analytical methods, regulatory guidelines, and cross-functional collaboration.
This opportunity is well-suited for professionals with hands-on experience in Analytical R&D documentation, regulatory submissions, and quality systems within the injectable pharmaceutical domain.
Prepare and maintain Standard Operating Procedures (SOPs), specifications, and methods of analysis for raw materials, in-process samples, and finished products
Review Drug Master Files (DMFs) to support preparation of analytical methods and specifications
Initiate and manage Change Control, Deviations, and CAPA documentation in compliance with quality systems
Ensure documentation aligns with current regulatory agency expectations and global compliance standards
Demonstrate strong understanding of impurity profiling and analytical evaluation
Apply thorough knowledge of ICH Quality Guidelines and major Pharmacopoeias (USP, EP, IP, BP)
Support regulatory readiness through accurate, compliant, and audit-ready documentation
Coordinate effectively with cross-functional teams including Analytical R&D, Quality Assurance, Regulatory Affairs, and Manufacturing
Prepare high-quality written documents with clarity, consistency, and regulatory accuracy
Contribute to continuous improvement through openness to feedback and coaching
Quality-based Regulatory Submission Documentation – Advanced
Document Review and Evaluation as per quality and regulatory standards – Intermediate
CAPA Documentation – Advanced
Change Control Documentation – Advanced
Cross-Departmental Coordination – Advanced
Good Documentation Practices (GDP) – Intermediate
Laboratory Information Management System (LIMS) – Advanced
Strong written communication and technical documentation skills
High attention to detail and compliance-driven mindset
Bachelor’s Degree in B.Sc. – Required
Master’s Degree in M.Sc. – Preferred
Bachelor’s Degree in B.Pharm – Preferred
Master’s Degree in M.Pharm – Preferred
Minimum 4 years of relevant experience, with overall experience ranging between 4–7 years
Prior experience in Analytical R&D documentation for injectable products within a regulated pharmaceutical organization is essential
Amneal is an equal opportunity employer committed to building a diverse and inclusive workplace. Employment decisions are based on qualifications, merit, and business needs, without discrimination based on caste, religion, gender, disability, or any other legally protected status.
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