Executive, Formulation & Development Injectable

• Understanding of product development related activities of all injectable dosage forms for regulated market (General injectable and Onco products)
• Understanding of ANDA and 505b2 product filing.
• Exposure or knowledge to wide range of dosage form (liquid solution, lyophilized, suspension, emulsion etc.)
• Understanding of Drug device combination products and regulatory expectations.
• Exposure or Knowledge to equipment like high shear homogenizer, high pressure homogenizer, lyophilizer, microfluidizer, nano mill etc.
• Experienced in preparation and review of product development report, MFR, stability protocol, other study protocols, SOP etc.
• Basic understanding of implementation of QbD principles for formulation development (QTTP, CQA, CPP, CMA, Risk assessment and Control strategy etc.)
• Exposure or knowledge of various QMS documents like change control, Incidence, planned deviation, unplanned deviation etc.
• Basic understanding of API specification, DMF, Excipients specification, In-process specification, Finished product & Shelf-life specification of injectable products.
• Basic understanding of preparation and review of necessary documents required for ANDA submission and approval of products.
  

Sill and its level

Formulation Development - solution based injectables | AdvancedScale-Up and Process Optimization | IntermediateRegulatory Affairs and Compliance | GrowMaterial Science and Excipients Selection | IntermediateCross functional Coordination | IntermediateCoA & Analytical Data Review | AdvancedInvestigation & CAPA Management | IntermediateStability Testing | IntermediateProtocol Development and Documentation |IntermediateCross-functional Collaboration |IntermediateTechnical Troubleshooting | Grow

Qualifications

M Pharm

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.