IPQA-Otsuka Pharma, Ahmedabad

Role & responsibilities

• Ensuring compliance to GMP during day-to-day activities on shop floor.
• Review of day-to-day and online compliance.
• Performing SAP transaction as required.
• Timely performing sampling at different stages as per the requirement.
• Ensuring and giving clearance for various stages during day-to-day activities like, Line clearance in Dispensing, Mixing, Autoclave, Washing, Depyrogenation Tunnel, Filtration, Filling, Terminal sterilization, visual Inspection, labelling, packing.
• Collection of various samples as per the requirement.
• To review of GMP document.
• Identification of deviation through review and observation.
• Handling over the shift base change for continued operation.
• To review Manufacturing, Packing document, etc.
• To raise deviation in case of any abnormality found and inform to Section Manager for the same.
• To prepare BMR/ BPR by verification against DMBD, respective process Standard Operating Procedure and Validation recommendation and get it reviewed.
• To issue standard formats.
• To execute routine IPQA monitoring like volume check, critical control step verification during manufacturing of the product, sampling and periodic verification activities and to report to Section Manager in case of any abnormality is observed and will file deviation for the same.
• To review the GDP issues in production / QC / QA and logbooks.
• To review Preventive Maintenance, Breakdown maintenance and perform risk assessment and suggest immediate corrective actions. Report conclusion of preventive maintenance and breakdown maintenance to Section Manager.
• To verify raw material, primary packing material at the time of material issuance and material dispensing against Standard Material Requirement Form and approve the process step.
• To perform routine IPQA monitoring like volume check, critical control step verification during manufacturing of the product, sampling and periodic verification activities and if any deviation / abnormal observation in terms of noncompliance to Good Manufacturing Practice (GMP) observed, bring to the notice of Process Manager.
• To verify headspace oxygen and dissolve oxygen during in process monitoring.
• To verify secondary packing material at the time of issuance against Standard Material Requirement Form and approve the process step.

Preferred candidate profile

• Result orientated
• Communication skills
• Presentation skills
• Analytical skills
• Lateral coordination