Senior Officer
Job Description
Purpose
Incumbent will be primarily responsible for documentation compliance and process validation, as well as handling all Compression and Encapsulation machine operations during shifts
Position / Job Title
Senior Officer
Department
Manufacturing ( Tablets and Capsules)
Reporting To
Section Head
Location
Ambernath
Years of Experience
5+ Years
Dosage Form
Tablet and Capsule
Job Responsibilities / Deliverables
Timely, accurate, and online review of Batch Manufacturing Records (BMR), Electronic Logs (E-Logs), and Building Management System (BMS) records.
Identify and rectify documentation errors or inconsistencies prior to the next stage of manufacturing to ensure seamless compliance.
Provide training to relevant personnel on process validation outcomes and recommendations
Review electronic log data including audit trail events, logs and batch reports
Maintain NDPS material data and proper reconciliations
Oversee and manage daily production activities and process validations during assigned shift including progress tracking
Allocate workforce as per daily production plans and skill matrix
Conduct root cause analysis (RCA) for downtime events and implement corrective actions.
Qualifications & Pre-Requisites
B. Pharm / M. Pharm.
Should have good experience 5+ Years in OSD
Knowledge in regulated markets in OSD and acquaintance with 21CFR compliance.
Familiar with equipment cleaning, process validation protocols, and hold time studies
Additional notes
Role is expected to work in shifts.