07 Oct
|
Rubicon Research
|
Ulhasnagar
07 Oct
Rubicon Research
Ulhasnagar
Position / Job TitleExecutive (Reviewer). DepartmentQuality Control Reporting ToAssistant Manager (P3) / Manager (P4).LocationAmbernathYears of Experience6 to 10 yearsDosage FormSolid Oral / Nasal / Liquid. Job Responsibilities / Deliverables
• Preparation and review of Specification, SOPs, Protocols, Reports, summary sheets, water samples report etc. To review analytical raw data of LNB / AWR for compliance, correctness, and completeness.
• To handle and ensure completion of all incidences, OOS, Change Control, Deviations etc.
• To coordinate with external testing laboratory for the release of material within the time frame assigned.
• To ensure resources (Chemicals / Reagents / Analytical columns / Standards / Documents / Instruments / Equipment’s etc.) available to smooth line function whenever required.
• To perform the task assigned by the supervisor/HOD as and when required.
• Responsible to adherence of GLP and Health, Safety Environment system in Laboratory.
• Should have good written and communication skill.
Qualifications & Pre-Requisites
Preferably have following skill but not limitedas mentioned below;
• Bachelor / Master Degree of Science / Pharma.
• He should have valuable 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 and ensuring completion of all incidences, OOS, Change Control, Deviations 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 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 on work priority as per company policy.
• Responsible to ensure compliance to GLP, Health, Safety and Environm
📌 Executive (Ulhasnagar)
🏢 Rubicon Research
📍 Ulhasnagar