Rajneesh Kalia

About Rajneesh Kalia

To ensure that all processes are done in accordance with GMP requirements.To ensure adequate review of Batch manufacturing and testing documents in accordance with internal procedure and GMP requirement.Work Management and distribution of shifts to ensure optimal utilization of manpower.Review of APQR and Hold time study data.To support the internal audit/Regulatory/FDA audit with best of practices.Handling Extension of shelf life and code to code transfer of Raw and Packing materials through SAP HANA.Handling Effective Trainings and evaluation of Technical SOPs to each personnel for quality output.Support timely launch of products to market (New /Site Transfer) to support & facilitate launch ofproducts as per overall launch plan (New Product) & commercial product site transfer.Improve Product Robustness Perform Product Assessment of new & commercialized products and remediate the products based on outcome of assessment.Ensure timely closure of all QMS records within timeline.Perform GEMBA walk across the site as per schedule.Improve and Sustain Site Quality Index by Monthly Reviewing, analyzing and tracking the Quality index trend and derive action plan to improve Quality index parameters wherever site is not meeting the targets.Release of finished product in SAP after review of Completed BMR & BPR as per GDP and CGMP compliance.To ensure that all non-conformances are addressed through NCR & Corrective & Preventive Actions are taken.Training to personnel and record maintenance.Review, Approval and Preparation of SOPs through EDMS.Handling of Market Complaints and its closure rate in Track wise by Ensuring timely investigation, root cause analysis, CAPA initiation and closure of product quality complaints.Handling of Change control & Deviation and CAPA.Review of executed Batch Manufacturing Records and Packing Records and their release. Strengthen QA system to improve CGMP compliance by introducing or revising documents.

Experience

1. Quality Assurance

   SUN PHARMA

   Jan 2011 — Present · Baddi, IN

   To ensure that all processes are done in accordance with GMP requirements.To ensure adequate review of Batch manufacturing and testing documents in accordance with internal procedure and GMP requirement.Work Management and distribution of shifts to ensure optimal utilization of manpower.Review of APQR and Hold time study data.To support the internal audit/Regulatory/FDA audit with best of practices.Handling Extension of shelf life and code to code transfer of Raw and Packing materials through SAP HANA.Handling Effective Trainings and evaluation of Technical SOPs to each personnel for quality output.Support timely launch of products to market (New /Site Transfer) to support & facilitate launch ofproducts as per overall launch plan (New Product) & commercial product site transfer.Improve Product Robustness Perform Product Assessment of new & commercialized products and remediate the products based on outcome of assessment.Ensure timely closure of all QMS records within timeline.Perform GEMBA walk across the site as per schedule.Improve and Sustain Site Quality Index by Monthly Reviewing, analyzing and tracking the Quality index trend and derive action plan to improve Quality index parameters wherever site is not meeting the targets.Release of finished product in SAP after review of Completed BMR & BPR as per GDP and CGMP compliance.To ensure that all non-conformances are addressed through NCR & Corrective & Preventive Actions are taken.Training to personnel and record maintenance.Review, Approval and Preparation of SOPs through EDMS.Handling of Market Complaints and its closure rate in Track wise by Ensuring timely investigation, root cause analysis, CAPA initiation and closure of product quality complaints.Handling of Change control & Deviation and CAPA.Review of executed Batch Manufacturing Records and Packing Records and their release. Strengthen QA system to improve CGMP compliance by introducing or revising documents.

Education

• Amar Shahid Baba Ajit Singh Jujhar Singh Memorial College, Bela , Ropar

  Bachelor of Pharmacy - BPharm

  2003 — 2007