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0.0 - 5.0 years

2 - 6 Lacs

ahmedabad

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Posted 6 days ago

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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 2 months ago

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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 4 months ago

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1.0 - 5.0 years

3 - 4 Lacs

ahmedabad

Work from Office

Designation: Executive Qualification : B.Sc. / B. Pharm + MBA (Preferable) Job Specification: - Responsible for sourcing of APIs/RLDs for developmental projects in Regulated Markets. - Identifying Quality API Vendors for Strategic Sourcing. - Price Negotiation and timely delivery of APIs. - Ensuring delivery of material as per desired quality and project timelines. - Co-ordination and execution starting from PR tracking, PO conversion, Material delivery and Payment release. - Co-ordination with suppliers for arranging quality documents. - Co-ordination with product development team to keep track of various projects. - Co-ordination between internal & external stakeholders for prompt resolution to ensure timely dossier submission. - Tracking and Resolution of Analytical, Regulatory, IP related queries for development Projects. - Mandatory for candidates to have pharma industry experience.

Posted Date not available

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8.0 - 10.0 years

12 - 20 Lacs

vadodara

Work from Office

Lead the preparation, review, and submission of new regulatory dossiers for Solid Oral Dosage Forms (SODF), Injectables, and/or Ophthalmic products to regulated markets. Lifecycle,Labelling Management, Stakeholder,Team Leadership,Process Improvement

Posted Date not available

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