Monitoring & implementation of Quality assurance activities in the shop floor. Issue of BMR, BPR after receipt of shop floor and Verification, retrieval and maintenance. Check for adherences to QSP/MFR during manufacturing process. Random in-process checks for verification. Log books verification. Pre dispatch inspection and release of product. Implementation and Co-ordination for validations. Sampling of SFG/FG. Plan and co-ordinate for housekeeping audits, IQA, etc. Deviation and Change control handling. Data analysis of deviations, complaints. Line clearance for Dispensing, Manufacturing, coding / Printing, Packing, etc. Analysis of OOS, if any. Ensuring in-process instruments calibration. Raising Non conformances, CAPA and follow up. On-line inspections and on the job training. Third party audits if required. Compilation of data for annual product review. Principal Accountabilities Random in-process checks for verification 20% Testing of the Semi finished products / Finished Products in the shop floor (Manufacturing and Packing) for pouch leakage, shipper weight, clarity of printing, moisture content analysis, leak testing of pouches, disintegration test analysis Deviation and change control handling. 20% Issual and reconciliation of deviations and change controls in the shop floor (manufacturing , maintenance and packing area) after approval from the Manager. Line clearance for dispensing, manufacturing, coding / printing, packing, etc. 20% Check for adherences to QSP/MFR during manufacturing process. 20 % Plan and co-ordinate for housekeeping audits, IQA, etc. 20 % Qualifications Education, Experience, Skills Required Qualifications B.Pharma / M Pharma / M.Sc Minimum 2 Years Experience Preferred Qualifications Minimum 2 Years Experience Willing to Work in Shifts (First or Second) Adequate knowledge and understanding on the Quality Assurance activities. Adequate knowledge on Master formula records, Complaint handling, deviation handling, change control handling, Validations. Prior experience in Quality Assurance department of Pharmaceutical Industry is preferred. Other relevant information to the position This position develops an individual to grow for supervisory role. Job Quality Assurance/Food Safety Primary Location Navi Mumbai Schedule Full-time Job Type Standard Shift Day Jo
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