07 Oct
|
Rubicon Research
|
Ulhasnagar
07 Oct
Rubicon Research
Ulhasnagar
Position / Job TitleSr. Executive (Reviewer).DepartmentAnalytical Method ValidationReporting ToManager (P4) / AMV – Section Head (M1)LocationAmbernath Years of Experience06 to 10 YearsDosage FormSolid Oral / Nasal / Liquid. Job Responsibilities / Deliverables
• Responsible for work planning of method validation, method verification and method transfer activities for API and finished products.
• Arrange the Direct or In-direct analytical method transfer activities at different locations of Rubicon as well as different CMOs and successfully complete it with ownership.
• Actively participate in method troubleshooting with prompt resolution during method transfer or method verification activities.
• Preparation and review of SOPs, Analytical raw data, Protocols, Reports, Summary sheets for compliance, correctness, and completeness.
• To coordinate with the analytical development team to ensure timely availability of all pre-requisites required for validation and in case of discrepancies observed during validation / verification / transfer.
• To ensure resources (Chemicals / Reagents / Analytical columns / Standards / Documents / Instruments / Equipment’s etc.) are available to smooth line function whenever required.
• To perform the task assigned by the supervisor/HOD as and when required.
• If required, we need to provide support for QC as and when required.
• Responsible for adherence to the GLP and the Health, Safety and Environment system in the Laboratory.
• Candidate should have good writing and communication skills.
Qualifications & Pre-Requisites
Preferably have following skill but not limited as mentioned below.
• Bachelor / Master Degree of Science / Pharma.
• He should have good experience of analytical data review and valuable knowledge of Chemical analysis, instrumental analysis like HPLC/GC/UV/ IC/IR/KF/Dissolution.
• He should have experience of Handling, initiation, execution & approval of all incidences, investigations, file notes, ratification, OOS, OO
📌 Senior Executive (Ulhasnagar)
🏢 Rubicon Research
📍 Ulhasnagar