Senior Executive, Analytical R&D Documentation

You will be responsible for the following tasks: - Preparation of SOPs, Specifications, and method of analysis (Raw material, In-Process and Finished product) - Review of DMF to prepare Analytical method and specification - Initiating Change Control and Deviation - Demonstrating a good understanding of Impurity profiling - Being well versed with regulatory agency's current requirements - Having a good knowledge of ICH quality guidelines - Familiarity with Pharmacopoeia - Utilizing good communication and writing skills for preparing quality documents and coordinating with cross-functional teams Your skills should include: - Quality based Regulatory Submission Documentation - Advanced - Document Review & Evaluation as quality and regulatory standard - Intermediate - CAPA (Corrective and Preventive Actions) Documentation - Advanced - Cross-Departmental Coordination - Advanced - Change Control Documentation - Advanced - Good Documentation Practices (GDP) - Intermediate - Laboratory Information Management System (LIMS) - Advanced - Being open to feedback and coaching - Advanced Qualifications required for this role: - Bachelors Degree (BA/BS) B.Sc. - Required - Master Degree (MS/MA) M.Sc. - Preferred - Bachelors Degree (BA/BS) B. Pharm - Preferred - Master Degree (MS/MA) M.Pharm - Preferred About Us: Amneal is an equal opportunity employer that values diversity and inclusion, without discrimination based on caste, religion, gender, disability, or any other legally protected status. The Human Resources team at Amneal plays key roles such as: - Executive Role: Specialists in all aspects of people management, providing high-level input at a strategic level into all key business decisions. - Audit Role: Ensuring compliance with legal requirements and best practice employment policies and procedures. - Facilitator Role: Supporting, advising, and extending the ability of all areas of the organization to meet their objectives through effective employment practices. - Consultancy Role: Providing expert advice on workforce management, employee relations, and performance. - Service Role: Equipping the organization to deal with developments impacting employment matters, such as changes in legislation and the labor market.,