Position / Job Title
Executive/ Sr. Executive (Reviewer).
Department
Quality Control
Reporting To
Assistant Manager (P3) / Manager (P4).
Location
Ambernath
Years Of Experience
6 to 10 years
Dosage Form
Solid 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 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 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 Environment requirement.
