Sr. Executive (Reviewer) - GLP

Position /Job Title - Sr. Executive (Reviewer).

Department - Quality Control

Location - Ambernath

Years of Experience - 8 to 12 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 / Equipments 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.