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.

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