AMNEAL PHARMACEUTICALS PRIVATE LIMITED Looking for Tech Writer- F&D Core Documentation profile at Ahmedabad Full Time

Job Description

Designation : Executive / Sr. Executive

Position 02

Job Responsibilities ;

This is pure documentation role from F&D perspective where candidate will be working for F&D documentations.

Candidate must have exposure in formulation & development of dosage form (OSD / Injectable).

Experience in Formulation Development of solid oral dosage forms with a very good understanding of all facets of Formulation development.

Optimization of the formulation process parameters and trouble shooting in solid oral dosage forms.

• Literature survey, pre-formulation studies and formulation trials leading to identifying a suitable composition for the product.
• Identification and optimization of suitable process parameters and components for manufacturing the product.
• Formulation development (QBD) for regulatory and near regulatory markets.
• Preparation of SOP’s, PDP’s, Product Specifications Protocols, Reports and PDR (QBD) etc.
• Development and Scale up of products and optimization of the process.
• Conducting the stability studies for new products.
• Supervision of the exhibit/pilot batches manufacture.
• Preparation of technical regulatory documentation to support development work and manufacturing (includes protocols, reports, laboratory note books and batch records) to internals.
• Conducting of CFT’s with other supporting departments to reduce the gaps and fast moving of projects.
• Complex dosage forms instead of OSD like, Peptides, Transdermal, Injections, Cream, Ointment etc.
• Experience with 505 (b)(2) or NDA / IND is preferred.

Joiners who can join us in 30 days would be a preference .