Executive, Analytical R&D Documentation | Injectable, Ahmedabad

Essential Functions JOB DESCRIPTION Preparation of SOPs, Specifications, and method of analysis (Raw material, In-Process and Finished product) Review of DMF to prepare Analytical method and specification Initiate Change Control and Deviation. Good understanding for Impurity profiling Well versed with regulatory agency's current 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 teams. Skills 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) - Advancedopen to feedback and coaching - Advanced Education QUALIFICATIONS Bachelor's Degree (BA/BS) B.Sc. - Required Master Degree (MS/MA) M.Sc. - Preferred Bachelor's Degree (BA/BS) B. Pharm - Preferred Master Degree (MS/MA) M.Pharm– Preferred Experience 4 years or more in 4-7 Yrs About UsAmneal 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.