Executive, Analytical R&D Documentation | Injectable

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 agencys 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) - Advanced
• open to feedback and coaching - Advanced
  

Education
QUALIFICATIONS

• Bachelors Degree (BA/BS) B.Sc. - Required
• Master Degree (MS/MA) M.Sc. - Preferred
• Bachelors Degree (BA/BS) B. Pharm - Preferred

• Looking to get Placed? Try our Placement Guarantee Plan

  Get Hired
  Master Degree (MS/MA) M.Pharm – Preferred
  

Experience

• 4 years or more in 4-7 Yrs
  

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 its 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.