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[QUOTE=Guest-IJT;100408]QA/QC 21 years of experience Dr. ASHUTOSH KUMAR VERMA [B]Email [/B]: vermaakvmail AT rediffmail.com Working in Avon Organics Ltd as General Manager QA&QC Career Objective - To achieve distinguished recognition in industry and appreciations for work ethics, face the challenges, build reputation in an organization and satisfy ambition. Qualification - Highest Degree – M. Sc. (Chemistry) PhD - Specialization – Organic Chemistry - University – B.R.A.B.University, Muzaffarpur Total Experience (~20.5 Years) - About 6.5 Years in Formulation QC. - About 3.5 years in commercial Testing Laboratory(API’s & Formulations) - About 4.5 years in Research and Development (Analytical)(API’s & Formulations) - About 6 years in Bulk API QA/QC [B]Present Job profile [/B]: Working as a General Manager QA & QC in Avon Organics Limited (Arch Pharmalabs Limited) since Oct-2009. [B]- Responsibilities [/B]: - To “Appraise the QA and QC activities” daily. - Planning and execution of all functions of QA and QC departments. - Co-ordination with production to maintain quality standards. - To ensure, review, plan, implementation and updations of Plant activities are as per cGMP and system for regulatory compliance. - Internal Audits, investigation of OOS, Handling of deviations, Approval of Change controls, Vendor development and qualification, Validations, Training etc. - Reporting to CMD [B]Previous Employment [/B]: From August 2007 to September 2009 worked as a Deputy General Manager QC in pharmaceutical company “Unimark Remedies Limited” which is API processes approved by USFDA,EU Authority and audited by various customers. - Reporting – Senior Vice President Quality [B]Job Profile [/B]: Unimark Remedies limited - Planning and execution of all functions of QC departments. - Co-ordination with production to maintain quality standards. - To ensure, review, plan, implementation and updations of Quality Control activities are as per cGMP and system for regulatory compliance. - Participation in Internal Audits, investigation of OOS, Validations, Training etc. [B]- Software System policy [/B]: Preparation and review for 21CFR compliance: - Maintenance, Calibration and Qualification of HPLC Systems, [B]- Analytical method transfer [/B]: [B]- SOP and Qualification documents [/B]: [B]- Audit preparation [/B]: Preparation of Audit as per Audit plan related to QC activity (supporting functions). [B]- Stability study [/B]: Review of Stability protocols, Stability Data etc. Monitoring overall activities. [B]- Analytical method validation [/B]: Residual solvents, Cleaning methods, Monitoring overall activities. [B]- Compliance of Quality policy and on job trainings [/B]: New method, new instrument demonstration, failure of any testing, on confirmatory in laboratory, troubleshooting of QC Instruments, documentation, GMP and GLP practices etc. From May 2003 to August 2007 worked as a Senior Research Scientist(Analytical Research and Development) in “Ranbaxy Research Laboratory” - Reporting – Associate Director [B]Job Profile [/B]: Ranbaxy Research Laboratory - Planning and execution of all function in the API group. - Co-ordination with CRD & PDR Scientists to develop the analytical methods for the different market requirements for various molecules. - Provided support for the evaluation of new analytical methods published in pharmacopoeia forums and its implementation. - Transfer of the analytical methods to plant QC. - Training to subordinates. From July 2000 to May 2003 worked as a Manager Quality Control in pharmaceutical company “Virchow laboratories Limited” which is API processes approved by USFDA,EU Authority and audited by various customers. - Reporting – General Manager [B]Job Profile [/B]: Virchow Laboratories Limited [B]- To ensure, review, plan, implementation and updations of QC activities are as per SOP and system for regulatory compliance- These activities are as below [/B]: 1. Ensure timely Sampling and analysis of raw materials, in process samples, intermediates and finished products. 2. Calibration and Qualification of QC instruments as per schedule 3. Review of Standard operating procedure and specifications. 4. Review of Stability study. 5. Review and up gradation of Calibration procedures. 6. To develop Analytical method for R&D samples. 7. Analytical method development and validations. 8. To raise the new requirements, modification or repairing if any. 9. Instrumental or analytical method trouble shootings. 10. Laboratory investigations ( OOS, Atypical, deviations) - Supporting functions in customer and regulatory audits. From August 1996 to June 2000 worked as Assistant Manager in a Commercial Laboratory “Ashkot Analytical services” which is ISO 9001 certified laboratory. - Reporting – Laboratory Manager [B]Job Profile [/B]: Ashkot Analytical Services - Supervising day to day operation of laboratory. - Ensure calibration of all analytical instruments as per schedule. - Method development and validation as per the customer protocols. - Timely reporting of results. - Dealing with various customers to understand their requirements, - Planning and distribution of samples to the analysts. - Instrumental or analytical method trouble shootings. - Training to Analysts. - Maintaining the inventory of Laboratory Chemicals, Columns and stationary. From March 1995 to July 1996 worked as a Quality Control Executive in pharmaceutical company “Vista Pharmaceutical Limited” which is a Formulation Unit. - Reporting – Quality Control Manager [B]Job Profile [/B]: Vista Pharmaceuticals Limited - Sampling of Raw materials, Packing Materials and analysis as per standard test procedure. - In process analysis of Tablets and capsules. - Sampling and analysis of Finished Dosage forms. - Timely reporting of results. - Calibration of Analytical Instruments. - Instrumental or analytical method trouble shootings. From June 1991 to Mar 1995 worked as a Quality Control Incharge in pharmaceutical company “Achemic Pharmaceutical India Private Limited” which is a Formulation Unit. - Reporting – Plant Manager [B]Job Profile [/B]: Achemic Pharmaceutical India Private Limited - Sampling of Raw materials, Packing Materials and analysis as per standard test procedure. - In process analysis of Tablets and capsules. - Sampling and analysis of Finished Dosage forms. - Timely reporting of results. - Calibration of Analytical Instruments. - Instrumental or analytical method trouble shootings. [B]Previous Employment [/B]: From Feb 1990 to April 1991 worked as Trainee Quality Control Chemist in pharmaceutical company “Targof Pure Drugs Limited” which is a Formulation Unit. - Reporting – Quality Control Assistant Manager [B]Job Profile [/B]: Targof Pure Drugs limited - Sampling of Raw materials, Packing Materials and analysis as per standard test procedure. - In process analysis of Tablets and capsules. - Sampling and analysis of Finished Dosage forms. - Timely reporting of results. - Calibration of Analytical Instruments. Trainings Attended - Personality Development - Total Quality Management - 21 CFR - GMP, GMP Updates & GLP - General overview of cGMP requirements for testing in Pharmaceutical company - The self Audit Assessing Lab compliance - Analytical method transfer - Document management system related to SOP - Data Integrity Achievements Virchow Laboratories Limited - Upgraded the QC activities in regulatory compliance. - Changed all calibration SOP’s and aligned with regulatory compliance. - Stability study – Created stability schedule with stability calendar, evaluation of excursions is started with trend, changed stability protocol, SOP and summary report format and aligned with ICH guideline. - Developed habit of JIT (Just in time and time management) in QC unit to achieve the target successfully. - Shared knowledge, increased confidence of analysts and made team and teamwork. - Discussed practical problems of analysts and resolved. - Discussed listened valuable suggestions from QC analysts & implemented the same. - Awareness developed for the online activities in system compliance. - Changed documentation practices and made correct as good documentation practices. - Habit developed in team for good laboratory practices by checking online operations daily. - Prepared lists for all QC functions ( QC users, SOP’s, specifications, calibration schedule, standards, stability specifications, stability protocols, validations etc) - Raw data sheets are aligned with regulatory compliance. - Column management and reference standard, working standard management is created. - Followed the assignments in time and aligned all QC activities with ICH, cGLP... etc. - Identified the analytical method issues for two intermediates (Isoxamide and Isoxamine) and modified the methods which resulted in significant yield improvement. - Successfully faced USFDA in 2003. Achievements in Unimark Remedies Ltd - Successfully Handled all KRA with strong documentation, strong analytical work. Took leading ownership in validation task. Shared new guidelines, solved instruments problems. No any repetitions found in analytical work. No any non-confirmatory observed to superior, or any during regulatory audits. Completed work within the commitment time. - Developed in house specifications, methods to reduce the cost & to increase the productivity. - Developed habit of JIT (Just in time) in shift members to achieve the shift target successfully. - Identified the Analytical method issue for L-proline benzyl ester HCl and rectified the method issue which resulted in yield improvement as well as cost reduction of the intermediate. - Successfully Faced USFDA in Sep-2009 My Aim - My aim is always perform beyond the Expectations.[/QUOTE]
