Job Description

Review

Batch records BMRs BPRs, Audit trail of processing equipment critical and non critical equipment, equipment privileges ,unit operation, various shop floor related documents, BMS alarm reports , Equipment / instruments calibration certificates, logbooks, equipment Annual reports , equipment surface testing , calibration schedules of equipment ,Impact Assessments.

Shop floor activities-

Line Clearance and In-process Quality Assurance during production activity and sampling at different stages of Processing /Packing as per the requirement (MDI/DPI/DERMA). Calibration of IPQC instruments. Cleaning Validation/ Verification Rinse swab sampling, tear down study of difficult to clean parts of the equipment’s Critical process parameters monitoring.

QMS activities

Issuance of Annexures, Batch records additional pages in SAP. Shopfloor noncompliance investigation and compliance Preparation and Review of Sops and protocols  Preparation of Continuous process monitoring reports Internal audit observations compilation Work Experience

6 to 10 years

Education Graduation in PharmacyCompetencies