Assistant Manager

Job Description:

Responsibilities

• Managing in-process QA shopfloor team as a shift in-charge
• Well versed in the In-process Quality Assurance activities which includes review of BMR, BPR, Logbooks.
• Tracking of in-process samples and ensuring timely release of areas for manufacturing and packing.
• Review of Audit trails/ events and Alarms.
• Transactions in software such as SAP, DMS, QMS, e-Logs and other applicable software.
• Line clearance and inspect shop floor activities.
• Performing Assay calculation, in-process checks during manufacturing activities as per BMR.
• Reconciliation of batch at various stages of manufacturing and packing of the batch.
• To perform swab/ rinse sampling of manufacturing and packing equipment and submit samples to QC for testing.
• Monitoring of reject handling on shopfloor.
• Identification of opportunity of process and practice improvement on shop floor.
• Ensure all time compliance at manufacturing, packing and warehouse shop floor.
• Immediate reporting of observed non-compliance to IPQA In-charge/ QA Head.

Qualification & Expeirence

• B. Pharm/ M. Pharm/ M.Sc. With relevant experience in pharma.
• Must have knowledge of working on the shop floor as an in-process quality assurance.
• Exposure to various regulatory bodies such as US FDA, EU-GMP, MHRA, TGA
• Exposure to specific dosage forms like OSD, Liquid Orals, Nasal (optional)
• Effective communication, Team coordination and work in collaboration within compliance