Pramod Singh Bisht
Pharmaceuticals
Nainital,India
Summary
Highly competitive, self appetizer, disciplined and goal oriented professional with 13.5years of experience in Quality Control, Quality Assurance Laboratory and Quality Compliance in Pharmaceutical Industry. Conduct site Audit and compliance as per requirement and evaluate for next phase of updation as per current requirement of regulations Proficient in writing and reviewing detailed documents explaining about the work and its results, in terms of product purity, quality & safety. Audit trial review of all system software like empower and stand alone. Knowledge in the calibration procedures and basic troubleshooting of instruments. Possesses Analytical skills (knowledge of chromatography, chemical analysis etc.) Fully acquainted with the instrument calibrations / method validations jobs& Analytical Method Transfer with hands-on experience on working standards, OOS, OOT, Analytical Lab Error/GAP Analysis, Incidences, Deviation & preparation of SOPs/SPECs/STPs/Protocol as Analytical Method Transfer, Root cause analysis as per QMS compliance system requirement etc. Monitoring of Reconciliation and destruction for cGDP and GxP documents & record. Risk assessment & classification of Quality related issues. Showed competency in handling Q.C. operations and audits to achieve the desired results for organization. Working knowledge of various abalytical techniques and instrumentation including maintenance and troubleshooting of the analytical instruments.
Overview
2
2
Languages
15
15
years of professional experience
Work History
Senior Executive (QA of QC)
Sun Pharma Laboratories Ltd
East Sikkim, Sikkim
05.2017 - Current
- To monitor all activity in QC department as per GLP.
- To ensure the proper closing of OOS, Lab incident, OOC & OOT, Batch Rejection (RM, PM, FP & Stability) on time.
- To review the OOS, Lab incident, OOC, OOT, Non conformities and ensure that the defined procedure as followed by QC to identify the root cause and establishment of CAPA.
- To prepare, review of trend of all laboratory errors and effective CAPA implementation to reduce laboratory errors.
- To review the Log books/Formates, Electronic and Paper raw data generated in QC lab as secondary check by QA of QC.
- Preparation of monthly data for laboratory error for CQA reporting.
- Execute assigned activities within established timeframe(SOPs revised in a month, SOPs revisions pending beyond timeline.
- To participate in Computer System Validation.
- To ensure the audit compliance.Reduce Testing protocol as per SOP.
- Ensure compliance of the functional area with company Health and Safety Policies.
- Audit trial of all system software like empower and stand alone.
- All the QMS tools performed online by trackwise, and LIMS.
- Comprehensive review and verification of electronic data for QC Compliance.
- Presented and attended seminars on quality review.
- Any other responsibility given by Management.
Executive
Zydus Healthcare Ltd
Sikkim
01.2016 - 05.2017
- Executed analysis of Finish products using United States Pharmacopoeia (USP) Indian Pharmacopoeia (IP) and SOPs and in-house testing methods utilizing HPLC, UV, Dissolution and wet chemical techniques.
- To performed Process Validation, Analytical Method Validation/Verification, Analytical Technology Transfer.
- Performed all the tests like (Assay, Dissolution, Related Substances, Content Uniformity) online calculation in empower3.
- Responsible for Following All Relevant SOP, Safety and Company Guidelines.
- To Maintain Logbook, Protocols and Documents Related to Instrument Lab with respect to GDP.
- Perform testing, both wet and instrumental, according to SOP's testing protocols, or compendia (USP EP/JP).
Officer
Nectar Lifescience
Chandigarh, Punjab
12.2014 - 11.2015
- Experience with FDA, and WHO regulations and guidelines.
- Analysis of inprocess products like reaction monitoring by HPLC and GC.
- To Maintain Logbook, Protocols and Documents Related to Instrument Lab with respect to GDP.
- Perform testing, both wet and instrumental, according to SOP's testing protocols, or compendia (USP BP/IP).
Officer
Lark Laboratories Ltd
Bhiwadi, Rajasthan
01.2012 - 12.2014
- Sampling of Raw Material & Packaging Materials.
- Analysis of Raw Materials & Packaging Materials.
- Preparation of volumetric solutions & standard solutions.
- Analysis of Bulk, Semi finish & Finish product of tablets, capsules,& liquids.
- Sampling and analysis of water samples.
- Daily reporting to Section Head.
- To maintain the Log books of all instruments.
- To send the sample for outside laboratory,(Contract laboratory)
Education
M.Sc. - Biotechnology
B.Sc. - ZBC
Matriculation & Intermediate - Science Stream
Skills
- Conducted comprehensive audit trial evaluations
- Prepared monthly data for analysis and reporting purposes
- Conducted comprehensive data review for enhanced accuracy
- Enhanced quality control processes within industry-specific standards
- Executed quality control processes to enhance operational efficiency
- Compliance in QC labs
- Ensured compliance within QC laboratories
- Facilitated QC lab preparation for inspection
- Good Manufacturing Practices
- Oversaw management of contract testing laboratory operations
- Data processing software
- Strong computer skills
- Process Validation
- Analytical Method Transfer
- Implemented HPLC techniques for accurate chemical analysis
- Led successful implementation of cost-saving technology initiatives
- Conducted analytical testing techniques
- Streamlined project delivery by implementing efficient team collaboration strategies
- Dissolution apparatus
- Solid Novel Drug Delivery System
- Formulation improvement
- Analytical testing techniques
- Physical testing techniques
- FDA regulations
- WHO regulations
Languages
Hindi
English
Custom Section
Negotiable
Personal Information
Negotiable
Disclaimer
I hereby declare that all the statements furnished herein are true, complete and correct to the best of my knowledge and I also understand that in the event of any discrepancy found will automatically lead to rejection of my candidature.
Timeline
Senior Executive (QA of QC) - Sun Pharma Laboratories Ltd
05.2017 - Current
Executive - Zydus Healthcare Ltd
01.2016 - 05.2017
Officer - Nectar Lifescience
12.2014 - 11.2015
Officer - Lark Laboratories Ltd
01.2012 - 12.2014
Punjab Technical University - M.Sc., Biotechnology
Kumaun University - B.Sc., ZBC
Uttrakhand Board - Matriculation & Intermediate, Science Stream