Executive / Senior Executive - Formulation Development | Injectable

Responsibilities

• Responsible for development related activities of all Parenteral Products.
• Responsible for preparation and review of MFR for exhibit batch of Parenteral products.
• Responsible for indenting the raw materials, RLD, Packaging Material and other items required for product development as well as exhibit batches.
• Responsible for preparation and review of study protocol required for exhibit batch of parenteral products.
• Responsible for review of specification like API, Excipients, In-process, finished product, Shelf life etc. of Parenteral products.
• Responsible for review of specification of primary packaging material.
• Responsible for review of BMR and BPR of Exhibit batch.
• Responsible for supporting Regulatory affairs department for ANDA submission and responding CMC query.
• Responsible for preparation and review of PDR and other necessary documents of parenteral products required for ANDA submission.
• Responsible for preparation of SOP and different study protocols for product development.
• Responsible for reviewing GMP related documents as applicable.
  

Qualifications

Master's in pharmacy in Pharmaceutics with minimum 2 years of experience

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.