PurposeNew Position.
Position / Job TitleSr. Executive or AM
DepartmentAnalytical Method Validation
Reporting ToManager (P4) / AMV Section Head (M1)
LocationAmbernath
Years of Experience8 to 12 years
Dosage 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 good 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, OOT, Change Control, Deviations and CAPA etc. Responsible for ensuring completion of GLP activities.
- The candidate having experience in US-FDA/MHRA approved company is preferable.
- Knowledge of Chromeleon 7.2 software and Empower will be an added advantage.
- Should have skill to achieve deliverable task with minimum support for analysis.
Additional Notes
- Role is expected to work in all shifts.
- If required, the candidate should be ready to travel to all plant locations or CMO on work priority as per company policy.
- Responsible to ensure compliance to GLP, Health, Safety and Environment requirement.
