Officer
Job Description
Purpose
To perform shop floor activities and batch record review
Position / Job Title
Officer
Department
Quality Assurance
Reporting To
Section Head - QA
Location
Satara
Years of Experience
4 +
Dosage Form
Liquid
Job Responsibilities / Deliverables
Shop floor activities
Line clearance certification during product changeover
Proof checking of overprinted matter
Review of batch manufacturing and batch packaging records
Sampling of bulk finished and pack finished products
Pack line inspection and performing in-process checks
Cleaning validation sampling (Rinse and swab for chem. analysis) and protocol preparation.
Sampling and protocol and report preparation of process validation, Hold time study.
Monitoring of shopfloor activities through rounds, identification and notification of potential discrepancies
Review of master batch record documents
Other activities
SFG, FG code creation, batch no. issuance in SAP
Data logger placement and review of transit data.
Review of Audit-trails of production equipment / instruments
Review of artwork and related change controls
Maintaining product data excels.
Batch release related documentation and archival of documents in the software
Qualifications & Pre-Requisites
B. Pharm / M. Pharm / B. Sc. (Chem.) / M. Sc. (Chem.)
Hands-on experience in handling oral liquid/ potent formulation manufacturing environments.
Strong knowledge of cGMP, GDP, and regulatory requirements (USFDA, MHRA, EU, TGA)