Key Responsibilities
Shop Floor & IPQA Operations
Perform line clearance for dispensing, manufacturing, filling, and packaging operations.
Execute In-Process Quality Assurance (IPQA) checks during production and ensure strict compliance with Master Batch Records (BMR/BPR).
Monitor ambient environmental parameters, cleanroom conditions, differential pressure, and water system sampling.
Quality Management System (QMS)
Handle QMS elements including Deviations, Change Controls, Corrective and Preventive Actions (CAPA), and Out of Specification (OOS) investigations.
Conduct root cause analysis (RCA) using tools like 5 Whys and Fishbone diagrams for quality incidents.
Coordinate internal audits, self-inspections, and follow up on audit observations to closure.
Documentation & Batch Release
Review executed Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) prior to final batch release.
Draft, review, and periodically update Standard Operating Procedures (SOPs), Validation Protocols, and Qualification Reports.
Prepare Annual Product Quality Reviews (APQR/PQR) and trend reports for Critical Quality Attributes (CQAs).
Experience
2 - 3 Years
No. of Openings
1
Education
Graduate (B.Pharma)
Role
Quality Assurance Executive
Industry Type
Pharma / BioTech / Clinical Research
Gender
[ Male / Female ]
Job Country
India
Type of Job
Full Time
Work Location Type
Work from Office
Face Interview Location
Impact HR and KM Solutions Near Canada Corner Signal Ravi Chambers Basements Below Laminate Gallery, Nashik