Job Description
Position / Job Title
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.
