Pradeep Kumar Rout

Experience

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  Resil Chemicals

  Nov 2012 - Feb 2015

  Technical Officer Quality Assurance

  • Ensuring cGMP & GLP should follow in technical group. • Calibration and preparing SOP of Instruments.• Conducting wet analysis as per specification.• Issuing Certificate of Analysis. • Finish good sampling, Raw Material Sampling.• BMR & BPR verification and issuance.• Preparation of Analysis Report of Products.• To analyse various competitors samples and substitution products.• Conducting audits and maintaining EHS, ISO, GMP, OHSAS, SA8000 guideline in the premises. • Conducting wet analysis as per specification.• Working on SAP software, Ware house approval of various finish goods, raw materials.• Preparation of Analysis Report.• Document control & practices. Show less

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  Beloorbayir Biotech Ltd

  Mar 2015 - Feb 2016

  Quality Assurance Executive

  • Preparation and evaluation of VAQ (Vendor Questionnaires) and providing other relevant documents for both Domestic and International markets.• Review and approval of Specifications as per USP,BP,IP and other Pharmacopeia• Review and approval of Standard Operating Procedures(SOP)• Handling out of Specification (OOS), Out of trend (OOT), APQR, change control and customer complaint in coordination with other departments.• Carried out Internal audits in the other units of the company and also inter and intra departmental audits in compliance to the requirements as per industries etc.• Carried out Vendor audits and evaluation of vendors.• Control of SOP’s, BMR’s, STP’s etc..• Participated in Customers audits and Certification audits both National & International Regulatory certification audits like HALAL, KOSHER, ISO, GMP etc. Show less

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  CRADEL PHARMACEUTICALS PRIVATE LIMITED

  Feb 2016 - Sept 2021

  Head QA

  • Implemented QMS, GDP & cGMP at site as per customer’s requirements of P&G Limited, Wallace & Strassenburg Pharmaceuticals for Liquid Oral & Dry Solid Finished Formulation dosage.• KPI & APR system implemented for routine monitoring of employees performance and product performance.• Timely completion and submission of all documentation pertaining to the work done and co-ordination with other departments.• Systematic documentation system implemented for review and approval of raw data and analytical reports.• Incorporated system and documents related to Risk Assessment & Risk Mitigation and QRM • Handling out of Specification (OOS), Out of trend (OOT), APQR, change control and customer complaint in coordination with other departments.• Training as per revised guidelines of Schedule M, WHO-TRS.• Team leader in handling various customers, regulatory audits.• Trained in Vendor Audits, CMO Audits & Compliance. • Handling Software’s like INOVIA Software, SAP & ERP.• Validation and calibration.• SOP review and documentation review.• Coordination with various other business partners for maintaining QMS.• Training related to Schedule M, compliance, CAPA and cGMP. Show less

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  Abdos Oils

  Sept 2021 - Jan 2022

  Quality Manager
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  ABDOS OILS PVT LTD

  Sept 2021 - Jun 2022

  Quality Manager

  • Implemented QMS & cGMP, GDP for new setup of plant.• Trained all new manpower towards testing’s and documentation related to job.• Implemented new STP’s & SOP’s as per BIS, ISO and internal SOP’s.• Updated and revised all specification in SAP for better documentation purpose.• Developed new vendors for PM’s & RM’s.• Reduced costing of company related to manpower utilisation and testing and production of FG’s

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  Baidyanath Ayurved

  Jul 2022 - now

  Head Central Quality
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  GOODCARE Pharma Private Limited (A Baidyanath Group Company)

  Jul 2022 - now

  Head CQA

  Reviewer & Approver of Change control, CAPA, PNC, MNC, Exception etc.Review, approval and closure of Change Controls, CAPA in automated Software of Quality Management System.Ensure all change controls and CAPA are closing in timely manner.To review and follow up for timely closure of CAPAs implemented through various quality notifications.To verify the effectiveness of implemented CAPAs.Review of Self Inspection Notifications and ensure timely closure of actions suggested, assist in internal & external audits related activities.Assist in projects / system up gradation activities and ensure its completion as per timelines.To perform Gap analysis with respect to cGMP guidelines, current regulatory requirements & corporate policies/ SOPs.Responsible to participate in Quality Risk management exercises wherever required.Responsible for training Management and to ensure trainings to all the employees.Movement of SOPs/Protocol from training team to DMS manager for making effective after completion of Training.To ensure Updation of Organogram, TNI, Employee master list, Man power list, Job responsibility, Trainer & auditor qualification and requalification as per respective SOPs.Responsible to Route the SOPs and Formats after completion of training to "Effective" documents repository in Document Management System.Review and approval and making effective of all master documents such as Sops, formats, Protocols, BPRR, BPAR, Specifications, STPs, GTPs, APQR, SMF, VMP etc. in DMS Show less