Agin Pappachan
Thrissur
Summary
Biotechnology professional with an M.Sc. in Microbiology and over 6 years of experience in in-vitro diagnostics, regulatory consulting, and quality assurance. Manager – Operations at Osherr Biotech, specializing in tissue culture of indoor plants and banana seedlings. Expertise in regulatory compliance, QC, and laboratory techniques.
Overview
8
8
years of professional experience
Work History
Manager of Operations
Osherr Biotech
Thrissur
05.2024 - Current
- Established a tissue culture lab.
- Research on plants, media, and micropropagation of banana seedlings, as well as indoor plant varieties.
- Handling contamination, procurement, and QC.
Quality Officer
Iqzyme Medtech Pvt Ltd
Cochin
04.2022 - 12.2023
- Coordinate with clients regarding QMS projects and Indian MDR compliance
- Provide training and technical documentation
- Regulatory consulting for Medical device and IVD companies
- Supporting the closure of audit responses for companies audited under ISO 13485:2016, ISO 9001:2015 and MDR 2017 by certification bodies such as DNV GL, BSCIC, IR Class, International Certification Services (ICS), MTIC, and Zenith Quality Assessors
- Managed the team tasked with regulatory submissions for manufacturing and import licenses as per Indian Medical Rules 2017
Executive QA/QC
Rapha Diagnostics Pvt Ltd
Palakkad
03.2020 - 04.2022
- Overall in charge of QA department
- Played a key role in document preparation for the Company License renewal as per MDR Rule 2017
- Holding a position of Deputy Management Representative and part of MRM
- Part of ISO 9001:2015 & ISO 13485:2016 BSI Recertification Audit in 2021
- Controlled the quality of reagents used in different medical biochemistry tests, including diabetic screening, renal screening, lipid profile, and liver screening
- Conducted specific protein tests and special parameter tests
- Conducted blood and urine routine tests
Quality Controller
PMP Quality Control Lab
Thrissur
04.2019 - 02.2020
- Food and water quality testing
- Microbial environmental monitoring, swab test and ensure employee personal hygiene
- Analysis of QC result and documentation
Executive QA & Microbiologist
Agappe Diagnostics Ltd
Cochin
10.2017 - 12.2018
- IPQA in production, filling and packing area
- Sterility test for invitro diagnostic reagents, microbial environmental monitoring and bioburden testing
- Plan and control QA/QC activities, quality supervision and in process quality assurance (IPQA)
- Primary testing of haematology products
Education
Master of Science - Microbiology
Bharathiar University
01.2017
Bachelor of Science - Microbiology
Calicut University
01.2015
Skills
- Microbiology techniques
- Laboratory procedures
- Equipment knowledge with biochemistry, hematology, and urine analyzers
- UV-VIS Spectrophotometer
- GC-MS
- ISO 13485: 2016
- ISO 9001:2015
- Documentation compliance
- Technical documentation
- Device Master Files (DMF)
- Design History Files (DHF)
- Medical devices compliance
- In vitro Diagnostics compliance
- IMDR 2017
Languages
English (Fluent), Malayalam (Native), Hindi & Tamil (Conversational)
Passport Details
P9840528 Date of Expiry: 27-04-2027
Timeline
Manager of Operations
Osherr Biotech
05.2024 - Current
Quality Officer
Iqzyme Medtech Pvt Ltd
04.2022 - 12.2023
Executive QA/QC
Rapha Diagnostics Pvt Ltd
03.2020 - 04.2022
Quality Controller
PMP Quality Control Lab
04.2019 - 02.2020
Executive QA & Microbiologist
Agappe Diagnostics Ltd
10.2017 - 12.2018
Master of Science - Microbiology
Bharathiar University
Bachelor of Science - Microbiology
Calicut University
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