NMS Consultant
Website:
nmsconsultant.com
Job details:
JOB RESPONSIBILITIES
- Formulation development of Complex ophthalmic dosage form for ROW and regulated market.
- Good knowledge of design and development of ophthalmic formulations such as sterile solutions, suspensions, emulsions, gel, preservative free and multidose systems.
- Q1/Q2/Q3 equivalence, Pharmaceutical In-vitro studies, In-vivo PD studies for generic development.
- In depth know how on product development strategy, pathway, Container closure system, performance assessment, stability studies.
- Development using Quality by Design, Risk assessment and mitigation strategy for Product and process attributes.
- Should have good knowledge of ICH, MEPP, US/UK/ROW regulatory requirements and working in aseptic, sterile environment.
- Hands on experience on Lab-Pilot- Mfg. scale equipment, scale up principles, Batch mfg, process flow design and technology transfer of ophthalmic dosage form.
- Sterilization, Validation, homogenization, emulsification process understanding.
- Abreast with good document practices and adept in preparation, review of R&D, TT documents.
- Understanding on Specs, dossier studies and new requirements like nitrosamine risk assessment and risk mitigation strategies.
- PDR preparation and response to regulatory agency queries based on product need.
- Plan and execute the development projects as per timelines and guide junior scientist for experimental work and ensure milestone delivery.
Effective co-ordination with cross-functional teams and contributing to the delivery and achievement of milestones.
If interested pls contact 9589659889
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