8.0 - 13.0 years

7 - 13 Lacs

Ahmedabad

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Position: AM_ ADL Key Requirements: Conducting in-depth Literature and patent search and making formulation development plan for Solid oral and Liquid oral formulations Develop new formulation concepts, assists in the development of project plans, business analysis and feasibility assessments. Develop experimental programs, work plan and prioritize assignments to meet project objectives within defined timelines Review and analysis of experimental data and design of further experiments. Monitoring of stability studies and Data interpretation Formula and process optimization studies - Discussion/design, review and monitoring of PET trials, pH Establishment Trials and PDR Trials Identify and manage the potential risks within projects in a timely fashion Arrange and management inventories (RM, PM, RLD etc.) required for projects. Conducting root cause analysis and trouble shooting Co-ordinate with cross functional teams for smooth flow of projects Review of technical documents like QnQ, Draft specifications, PDR report and finalization, MFR, PVP, HTSP etc. Monitoring and providing technical support for scale up and validation batches Desired qualifications: M. Pharma Desired skills: Proactive self-starter who is comfortable working independently in a fast-paced environment while maintaining attention to detail Hands on experience in formulation development of solid orals and liquid orals for regulated markets Knowledge on QbD and DoE concepts Knowledge on Regulatory guidelines for USA/Europe/ROW markets Trouble shooting and Root cause analysis skills

Posted 19 hours ago

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Urgent Hiring | Executive/Sr.Executive- F&D (liquid Orals) Marksans Pharma

4 - 9 years

7 - 10 Lacs

Navi Mumbai

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We have urgent opening for Executive/ Sr.Executive - FR&D (liquid orals) JD for Liquid Oral dosage form: 1. Experience in formulation & Development of liquid oral dosage form (Solutions & Suspensions) in regulatory market (US/EU/Aus). 2. To conduct literature search, patent search of assigned project and should be familiar with regulatory guidances. 3. To prepare application for form 29, form 11, RLD import license, form 25 etc. 4. To procure raw materials (API/Excipients), Packing material and Innovator samples in consultation with packaging/Regulatory & Purchase department. 5. To execute pre-formulation and formulation optimization trials with QbD approach and develop a robust formulation. 6. To manufacture batches for stability studies and perform other studies on optimized formulation. 7. To review analytical reports and prepare compilation sheet and discuss with superiors. 8. To co-ordinate with cross functional departments like Analytical, Regulatory, QA, MS&T etc. 9. To prepare Technology transfer documents like MFC, PDR, Stability Protocols, Risk assessment and execute scale up and Exhibit batches. 10. Address the regulatory queries. Interested Candidate may send their resume on email Id : audrey.fernandes@marksanspharma.com Regards, Audrey Fernandes Asst.Manager-HR

Posted 1 month ago

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