SHILPA VARGHESE
Ernakulam
Summary
Intelligent Quality Manager with talents in monitoring production quality and improving productivity. Deep understanding of the tools and concepts that go into quality management. Flexible, and reliable and ensure standards meet expectations and legal compliance.
Overview
24
24
years of professional experience
Work History
Microbiologist Trainee
Doctors Diagnostic centre
Ernakulam
06.2000 - 12.2000
- Performed laboratory experiments and monitored microbial growth in various cultures.
- Prepared samples for analysis using sterile techniques.
- Analyzed data from microbial tests and reported results accurately.
- Assisted in the development of protocols for quality control processes.
- Maintained accurate records of all experiments conducted in the lab.
- Utilized advanced equipment such as microscopes and autoclaves to analyze samples.
- Monitored environmental conditions in laboratories to ensure safety standards were met.
Microbiologist
SDS Laboratory
Ernakulam
01.2001 - 07.2002
- Assisted with the development of laboratory protocols related to sample processing, analysis, and reporting of results.
- Monitored microbiological tests including sterility testing, total plate count, bioburden testing and endotoxin testing.
- Utilized various techniques such as microscopy, flow cytometry, ELISA, culture media preparation for identification of microorganisms from clinical specimens.
Executive Product Management
Agappe Diagnostics Ltd
Ernakulam
07.2002 - 06.2008
- Developed and managed product life cycle plans to ensure successful introduction of new products.
- Prepared presentations, reports, and financial analysis to support product launch decisions.
- Identified potential partnerships with external vendors to enhance existing products.
- Conducted competitive research and benchmarking studies to inform pricing strategies.
- Coordinated internal teams across departments such as sales, marketing, engineering, and operations to ensure efficient product development processes.
- Gathered requirements from stakeholders for new features or functionality in the product roadmap.
- Managed multiple projects simultaneously while meeting deadlines on time.
- Provided guidance and mentorship to junior members of the product team.
- Generated detailed project timelines including milestones, deliverables, resources needed.
- Assessed customer pain points through surveys and interviews to inform product design decisions.
- Facilitated brainstorming sessions with cross-functional teams to generate ideas for new products or services.
- Developed marketing strategies based on corporate objectives and market trends.
- Collaborated with other departments to coordinate strategic marketing activities.
Application Support Specialist
Agappe Diagnostics Ltd
Ernakulam
07.2008 - 04.2013
- Provided application support and maintenance for clients, troubleshooting any issues that arose.
- Resolved user inquiries related to product complaint via,telephone email and Directly by visiting the site.
- Identified root causes of application errors and implemented solutions to prevent recurrence.
- Tested application functionality prior to release into production environment.
- Collaborated with development teams on design specifications for new applications or features.
- Provided training sessions to users on how to use specific applications effectively.
- Reported incidents promptly according to company's incident management policy procedures.
- Responded quickly to customer requests regarding application problems or changes.
Senior Quality Manager
Agappe Diagnostics Ltd
Ernakulam
05.2013 - 07.2019
- Developed and implemented quality management systems to ensure product compliance with industry standards.
- Monitored production processes, identified issues, and implemented corrective actions to minimize customer complaints.
- Conducted internal audits of manufacturing processes to ensure adherence to quality system requirements.
- Provided guidance on regulatory requirements for new products and existing products.
- Reviewed customer feedback data to identify areas of improvement in the quality management system.
- Collaborated with cross-functional teams to develop strategies for improving product quality.
- Performed root cause analysis and developed corrective action plans following customer complaints or non-conformances.
- Investigated supplier performance issues and reported findings to senior management team.
- Created reports documenting process improvements and their impact on product quality levels.
- Maintained database of customer complaints, including resolution timeframes and corrective actions taken.
- Assisted in developing training materials related to the quality management system and its implementation across various departments.
- Developed procedures for testing incoming raw materials as well as finished goods prior to shipment.
- Implemented a system of continuous improvement initiatives aimed at increasing efficiency while maintaining high levels of product quality.
- Analyzed data from periodic surveys conducted by customers regarding satisfaction levels with our products and services.
- Managed documentation control activities related to the QMS including versioning, archiving and distribution of documents.
- Provided technical support for external auditors during annual ISO 9001 certification audits.
- Reviewed standard operating procedures or quality assurance manuals to refine production processes or update for conformity to new regulations or policies.
- Monitored execution of testing activities, directing supervisors, inspectors and floor workers according to testing specifications to gather accurate, useful data.
- Managed company onboarding processes, interviewing and selecting new quality assurance personnel.
- Analyzed quality control test results and provided feedback and interpretation to production management or staff.
- Established product specifications and quality assurance practices.
- Monitored product trends and suggested changes.
Sr. Manager Product Evaluation
Agappe Diagnostics Ltd
Ernakulam
08.2019 - Current
- preparation of Product validation plan
- Proper product validation as per the industry standards in coordination with R&D and Business development and strategy
- Pilot batch production of reagents and evaluation
- Application of reagents in various analyzers
- Pack size and Bill of material preparation
- Licensing and approval of reagents from regulatory affairs
- Technology transfer to production & commercial batch preparation
Education
Master of Science - Microbiology
Periyar University
Tamil Nadu12-2015
Bachelor of Science - General Microbiology
PEEGEE College of Arts & Science
Tamil Nadu04-2000
Skills
- Customer complaint Handling
- Quality Control Procedures
- Data analysis and Interpretation
- Internal auditing
- ISO 13485 & 9001 documentation
- Statistical Analysis
- Project management
- Research and trend analysis
Languages
Malayalam
First Language
English
Proficient (C2)
C2
Hindi
Advanced (C1)
C1
Tamil
Beginner
A1
Timeline
Sr. Manager Product Evaluation
Agappe Diagnostics Ltd
08.2019 - Current
Senior Quality Manager
Agappe Diagnostics Ltd
05.2013 - 07.2019
Application Support Specialist
Agappe Diagnostics Ltd
07.2008 - 04.2013
Executive Product Management
Agappe Diagnostics Ltd
07.2002 - 06.2008
Microbiologist
SDS Laboratory
01.2001 - 07.2002
Microbiologist Trainee
Doctors Diagnostic centre
06.2000 - 12.2000
Master of Science - Microbiology
Periyar University
Bachelor of Science - General Microbiology
PEEGEE College of Arts & Science
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