Renu Agrawal
Senior Quality Engineer_QMS & Sterilization (Microbiology) at Merit Medical Singapore- Claim this Profile
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Bio
Margaret O Halloran
Renu is a talented microbiologist with skills in sterilization validation, QMS, project management and regulatory affairs.
Ajith Vijayakumar
Renu is a fantastic professional, who tries to understands the requirements, timeline and circumstances completely and performs her duties. She really communicates well, which helped project leaders like me and the team to be in sync, which really helps the project leader and management to take meaningful decisions. She is a individual who really dedicates the time for professional work when at work, and puts in more extra hours if needed to make the team succeed and to help herself from overloading as she is very capable of managing multiple projects at the same time. She really has displayed good managing skills and really likes to educate (knowledge transfer) and make the team learn new stuff or the necessary stuff the team needs to know. With her in the team, I would not have to worry about the tasks that she is responsible for, as timely communication and highlighting issues happen. Great Asset to the company and great team player. A individual with great potential! I have really seen her going an extra mile and taking interest and responsibility to learn things and the reality on the other side, that might influence her work or affect the teams delivery on time. If there's any opportunity to work together again, I will be more than happy to have her in my team!
Margaret O Halloran
Renu is a talented microbiologist with skills in sterilization validation, QMS, project management and regulatory affairs.
Ajith Vijayakumar
Renu is a fantastic professional, who tries to understands the requirements, timeline and circumstances completely and performs her duties. She really communicates well, which helped project leaders like me and the team to be in sync, which really helps the project leader and management to take meaningful decisions. She is a individual who really dedicates the time for professional work when at work, and puts in more extra hours if needed to make the team succeed and to help herself from overloading as she is very capable of managing multiple projects at the same time. She really has displayed good managing skills and really likes to educate (knowledge transfer) and make the team learn new stuff or the necessary stuff the team needs to know. With her in the team, I would not have to worry about the tasks that she is responsible for, as timely communication and highlighting issues happen. Great Asset to the company and great team player. A individual with great potential! I have really seen her going an extra mile and taking interest and responsibility to learn things and the reality on the other side, that might influence her work or affect the teams delivery on time. If there's any opportunity to work together again, I will be more than happy to have her in my team!
Margaret O Halloran
Renu is a talented microbiologist with skills in sterilization validation, QMS, project management and regulatory affairs.
Ajith Vijayakumar
Renu is a fantastic professional, who tries to understands the requirements, timeline and circumstances completely and performs her duties. She really communicates well, which helped project leaders like me and the team to be in sync, which really helps the project leader and management to take meaningful decisions. She is a individual who really dedicates the time for professional work when at work, and puts in more extra hours if needed to make the team succeed and to help herself from overloading as she is very capable of managing multiple projects at the same time. She really has displayed good managing skills and really likes to educate (knowledge transfer) and make the team learn new stuff or the necessary stuff the team needs to know. With her in the team, I would not have to worry about the tasks that she is responsible for, as timely communication and highlighting issues happen. Great Asset to the company and great team player. A individual with great potential! I have really seen her going an extra mile and taking interest and responsibility to learn things and the reality on the other side, that might influence her work or affect the teams delivery on time. If there's any opportunity to work together again, I will be more than happy to have her in my team!
Margaret O Halloran
Renu is a talented microbiologist with skills in sterilization validation, QMS, project management and regulatory affairs.
Ajith Vijayakumar
Renu is a fantastic professional, who tries to understands the requirements, timeline and circumstances completely and performs her duties. She really communicates well, which helped project leaders like me and the team to be in sync, which really helps the project leader and management to take meaningful decisions. She is a individual who really dedicates the time for professional work when at work, and puts in more extra hours if needed to make the team succeed and to help herself from overloading as she is very capable of managing multiple projects at the same time. She really has displayed good managing skills and really likes to educate (knowledge transfer) and make the team learn new stuff or the necessary stuff the team needs to know. With her in the team, I would not have to worry about the tasks that she is responsible for, as timely communication and highlighting issues happen. Great Asset to the company and great team player. A individual with great potential! I have really seen her going an extra mile and taking interest and responsibility to learn things and the reality on the other side, that might influence her work or affect the teams delivery on time. If there's any opportunity to work together again, I will be more than happy to have her in my team!
Credentials
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Risk Management Specialized Credential
ASQ - World HeadquartersJan, 2023- Oct, 2024 -
Risk Management Specialized Credential
ASQ - World HeadquartersJan, 2023- Oct, 2024
Experience
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Senior Quality Engineer_QMS & Sterilization (Microbiology)
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Jul 2021 - Present
Responsible for assurance of sterility of all products labeled as sterile, compliance and implementation of sterility assurance program that encompasses contamination control, sterilization, and microbiological / chemical testing. •Provides microbiological and sterility expertise in Design Change Control, Packaging, Sterilization, QA Laboratory, facilities and other related manufacturing operations and key Plant initiatives •Develop and implement policies within QA to ensure Plant’s Quality System complies with 21 CFR Part 820- Quality Systems Regulation, ISO 13485, Medical Devices Regulation (MDR), Medical Device Regulations ( Canada) and any other applicable standards & government regulations including effectiveness review of system for continual improvement. •Environmental microbiologists, exposure in the microbial processes in the environment. •Provides QA Laboratory support to process engineering, production and other operational support. •Facilitate knowledge transfer sessions via In-House Trainings. •Participating & providing technical support for Sterilization (EO) including sterilization validation, requalification and maintenance of routine sterilization process to ensure product meets required SAL. •Providing technical support during change control management which may impact on product integrity •Provide guidance in root cause analysis, nonconformity report in area related to but not limited to QA laboratory, Environmental monitoring activities and sterilization and partake in Material Review Board meetings when required. •Ensuring that the quality system requirements are established and maintained in accordance with international and US regulatory requirements. •Performing Internal Audit •Provides expertise and/or leadership in key functions areas such as external/internal quality audit program, CAPA system management, compliance metrics and quality management review •Facilitate knowledge transfer sessions via In-House Trainings, and Public forums. Show less
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Merit Medical Systems, Inc.
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Microbiologist
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Oct 2016 - Jul 2021
A Microbiologist, with extensive knowledge in Microbiological methodologies & quality tools, with over 15 years of Quality Assurance and Microbiological testing experience across all aspects of quality operations, laboratory control, Inventory management, process quality control and quality assurance activities in Pharma /Medical device and FMCG The breadth of my experience is across Medical device/Pharmaceuticals to Beverage company, Performing FEMCA [failure effective mode critical analysis],problem solving etc. My domain expertise snapshot: •Environmental microbiologists, exposure in the microbial processes in the environment. •Expertise in Yeast Management, Fermentation, brewing process •Expertise in document management.[GDP] •Exposure to ISO/BIS and USP methodologies. •Strong Quality Control skills with structured methods in quality testing. •Expertise in quality analysis •Facilitate knowledge transfer sessions via In-House Trainings, and Public forums. •Planning own work for all activities in Microbiology Lab. •Performing Microbial Limit Test (MLT) for Finished Products. •Performing Environmental monitoring by settle plates method, Air Sampling method and contact plate method. •Performing Water Testing as per international standards. •Performing microbial identification (Bacteria, mold and yeast) in water, environment and product samples. •Perform Bio burden analysis for intermediate product. •Reference culture preservation and maintenance. •Media Preparation, sterilization and performing Growth promotion test for prepared media as per ISO •Supporting to Cleaning validation for equipment with respect to the microbiology. •Involved in review of Change Controls, Deviations/Investigation as well as Test Methods. •Performing Investigations and analysis to find out the root cause for the OOS and Deviations. . Method Validation/Verification Show less
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Sunningdale Tech Ltd
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Singapore
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Plastics Manufacturing
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400 - 500 Employee
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Microbiologist
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Sep 2013 - Sep 2016
Sunningdale Tech Ltd. is a leading precision tooling, plastic injection molding and precision assembly company providing a broad spectrum of capabilities that includes pre primary packaging material to Healthcare Company, Mould designs etc. Responsibilities: • Responsible for daily Microbiological lab testing activities. • Prepare, review and implement test methods or SOPs relating to microbiological testing. • Ensure proper inventory management of laboratory consumables, microbiological Media, etc. • Perform Environmental Monitoring in clean room and controlled environment like Non viable particle count [ISO 14644], viable air borne particle count, Surface Monitoring through RODAC plate. • Supporting to Cleaning validation for equipment with respect to the microbiology. • Performing Investigations and analysis to find out the root cause for the OOS/OOE and Deviations. • Performing Qualification for laboratory equipment to qualify for testing. • Managing Vendors and external laboratory services for inventory maintenance and services. • Maintain all necessary records like equipment qualification reports, Equipment calibration records and all completed test results. • Performing Microbial identification C.sakazakii, enterobacter into per packaging materials. • Participating in internal audit for ISO 13485 • Supporting to production team for clean room qualification at three stages. • Supporting to business development team for any new project related to microbiology Show less
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Microbiologist
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May 2012 - Aug 2013
An Experienced Microbiologist: --> Laboratory Set-up and management • Responsible for new microbiology laboratory setup, negotiations with suppliers and customers for specific company needs. • Performing and Overseeing product Bio-burden test, Sterility test, Biological Indicator monitoring, Checks of Water& Saline for HPC, Coliform Bacterial Count and Environmental Monitoring in production floors (Viable, Non-viable and surface monitoring). • Carry out regular and non-routine microbiological testing and environmental monitoring for medical device manufacturing facility e.g air monitoring, swab testing, etc. • Conduct microbiological testing – preparation of media, testing of bulk, finished products, stability products, etc. --> Reporting, Documentation & Analyis • Experienced in Current Good Laboratory Practices (cGLP) and Good Documentation Practices (GDP). • Prepare, review and implement test methods or SOPs relating to microbiological testing. • Inventory management of laboratory consumables, microbiological Media and peripherals, etc. • Maintain testing equipment in microbiological lab. • Perform variance or laboratory investigations and document out-of-spec or inconsistent situations. • Co-ordinate and arrange samples for investigation with multi party stake holders. Show less
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QC Analyst
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Aug 2011 - May 2012
Beacons is the largest generic pharmaceutical manufacture in Singapore, Specializing in all major therapeutics in variety of dosage from tablet & capsule to ointment, Cream & liquid. Responsibilities: Lead Process control through in process quality checks & inspection. Highlighting the critical area, risk zone & and investigate problems through quality tools to prevent the product defects. • Laboratory upkeep with analysis of raw material, in process & finished product checks. • Lead product validation, cleaning validation & method validation. • Participates in QC team for new project and in GMP Team activity. • Partially involve in Microbiological analysis like Air monitoring, water tasting,MLT • Hands on experience on FTIR, spectrophotometer, Dissolution. • Follow up any nonconformity with CAPA and ensure CAPA action efficiently implemented. Show less
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SABMiller
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Food & Beverages
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700 & Above Employee
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Microbiologist - Quality
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May 2006 - Jan 2011
A leading MNC (World’s second largest) in Beer manufacturing with brands like Foster’s, Hayward’s, Indus Pride, Royal Challenge, Black Partridge etc. Responsibilities: Leading role as the Microbiologist in Brewing Industry. Assurance delivery of results on time for continuous production with adherence to specification. Lead process control through visual management & microbiological analysis, Identify and track Defects and Problem Resolution via quality tools like fish bone, 5 why, control charts, group discussion, training etc. Show less
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Education
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2021 - 2021
BSI Training Academy
Implementation of Medical Device Regulation (MDR) for CE Marking training course -
2021 - 2021
BSI Training Academy
Understanding of FDA21CFR part 820 Quality System Regulation -
2020 - 2020
BSI Training Academy
ISO14001:2015 Internal Auditor Exam -
2016 - 2016
GT Consultancy
Understanding the requirement of ISO13485:2016 -
2014 - 2014
SGS Academy
ISO14971:2007 Risk Management of Medical Device -
2014 - 2014
GT Consultancy
Certificate course, Supplier Quality Management -
2013 - 2013
SGS,Singapore
Internal auditor course-ISO13485 -
2010 - 2011
Institue of Brewing & distillation
Certificate course, General certificate in Brewing[GCB] -
2008 - 2009
Bioinformatices Institue
Diploma, Diploma in Quality control & Quality assurance in pharmaceutical -
2006 - 2007
Rajasthan University Jaipur
Master of Science, Microbiology -
2014 -
SGS,Singapore
certification course, Certificate course I SO 14971 Risk Management for medical devices
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