Job Purpose To ensure compliance with cGMP and regulatory requirements during manufacturing packing and in-process activities by effective implementation of IPQA systems documentation review and continuous monitoring of shop-floor operations Key Responsibilities 1 In-Process Quality Assurance Ensure line clearance before start during changeover and after completion of manufacturing packing activities Monitor critical process parameters CPPs and critical quality attributes CQAs Verify adherence to BMR BPR during execution Ensure proper status labeling and material movement control 2 GMP Compliance Ensure compliance with WHO-GMP Schedule M USFDA EU-GMP as applicable Conduct regular shop-floor GMP audits Identify deviations non-conformances and initiate corrective actions 3 Documentation Review Review and approve o Batch Manufacturing Records BMR o Batch Packing Records BPR o Logbooks and in-process records Ensure timely closure of deviations incidents and OOS OOT Review change controls related to manufacturing and packing 4 Deviations CAPA Investigations Initiate and investigate deviations incidents and market complaints Prepare and implement CAPA with defined timelines Track effectiveness of CAPA 5 Validation Qualification Support Support process validation cleaning validation and equipment qualification Review validation protocols and reports from IPQA perspective 6 Training Team Management Train IPQA officers executives on o GMP practices o SOPs o Regulatory expectations Allocate duties and monitor team performance 7 Regulatory Audit Support Support internal audits customer audits and regulatory inspections Prepare and review responses to audit observations related to IPQA 8 SOP Management Prepare review and implement SOPs related to IPQA activities Ensure SOP compliance on the shop floor Authority To stop manufacturing packing activity in case of critical GMP non-compliance To approve reject in-process activities as per quality standards To recommend corrective and preventive actions Qualification Experience B Pharm M Pharm M Sc Chemistry or relevant discipline 8-12 years of experience in IPQA in pharmaceutical manufacturing Exposure to regulatory audits WHO USFDA EU etc preferred Skills Competencies Strong knowledge of cGMP Schedule M and regulatory guidelines Excellent documentation and investigation skills Leadership and team-handling ability Valuable communication and coordination with Production QC and Engineering Problem-solving and decision-making skills Key Performance Indicators KPIs Reduction in deviations and repeat observations Timely batch release support Audit compliance and inspection outcomes Effective CAPA implementation Job Types Full time Permanent Pay From 100 000 00 per month Benefits Cell phone reimbursement Food provided Paid sick time Paid time off Work Location In person