Officer
Job Description
Purpose
To perform shop floor activities and batch record review
Position / Job Title
Officer
Department
QA-Operations
Reporting To
Section Head
Location
Satara
Years of Experience
2-3 Years Experience
Dosage Form
Liquid
Job Responsibilities / Deliverables
Shop floor activities
Sampling and execution of process validation/cleaning validation
Packing line inspection and sampling of Bulk Finished & finished products
In-process checks and proof checking
Issuance and review of batch records
Line clearance, EMRM approval
Sound knowledge and experience as a shop floor QA
Experience in cleaning validation
Experience of working in USFDA/MHRA approved plant.
SAP related activities
Review of master batch documents.
Monitoring of shopfloor activities through rounds, identification and notification of potential discrepancies
Review of Audit-trails of production equipment / instruments
Data logger placement and review of transit data.
Batch release related documentation and archival of documents in samwed.
Qualifications & Pre-Requisites
B. Pharm / M. Pharm / B.Sc. (Chem.) / M.Sc. (Chem.)