M. Doraswamy
Microbiologist
Hyderabad,AP
Summary
Having 14 years of professional experience in the Microbiology department, Experience in aseptic processing activities, environmental monitoring, aseptic gowning, microbial method validation, and microbial monitoring trends reporting. Comprehensive knowledge and interpretation of cGMP, cGLP, WHO, and USFDA regulations. Maintain positive relationships and networks effectively across the organization.
Overview
14
14
years of professional experience
Work History
Assistant Manager
Bharat Biotech International Limited
07.2023 - Current
Assistant Manager
Ichor Biologics Pvt.Ltd
04.2022 - 05.2023
Deputy Manager
Kimia Biosciences Ltd.
11.2020 - 01.2022
Team leader
Venkata Narayana Active Ingredient pvt.ltd
11.2018 - 12.2019
Sr. Executive
Aurobindo Pharma
10.2015 - 06.2018
Executive
Hospira Healthcare India Pvt.Ltd
12.2011 - 09.2015
Trainee Executive
Doctors Life Sciences Pvt. Ltd
06.2011 - 12.2011
Education
MS/M.Sc. - Microbiology
Acharya Nagarjuna University
01.2008
B.Sc - Biology
Sri Venkateshwara University (SVU)
01.2006
Skills
- Good Communication Skills
- Quick Learning
- Water Validation
- QMS
- OOS
- OOL
- GLP
- Validations for BET
- Validations for sterility
- Validations for MLT
- SOP Preparation
- Protocol Preparation
- Hold time studies
- Microbiology lab qualification
- Cleaning Validation
- Equipment qualifications
- Instrument qualifications
Personal Information
- Total Experience: 14 years
- Date of Birth: 1986-08-19
- Gender: Male
- Marital Status: Married
Work Profile
- Microbial Limit test - Raw materials, In-process bulk samples, finished products, compressed gas samples, cleaning validation samples like swab and rinse water.
- Water analysis – Raw water, Potable water, Purified water, Water for Injection (WFI), and pure steam condensate.
- Biological indicators – Initial qualification of various types of BIs, Recovery test.
- Microbiology Environmental Monitoring by Passive and Active air sampling method (Mas 100, AES &SAS), personnel monitoring by Finger dab, Contact plate.
- Environmental monitoring Swab analysis by membrane filtration method.
- Media preparation, Inventory, and Qualification (GPT).
- Initial qualification of Bio balls, and cultures. Handling of culture and culture suspension preparation.
- Preparation of Water and Environmental Trends.
- Operating of Instruments and Equipments in Microbiology lab of different make.
- Maintaining all records of activity in daily basis.
- Water system Qualification.
- Microbiology lab Design and facility qualification.
- Clean room Qualification by viable monitoring.
- QMS activity related Microbiology.
- SOP, Protocol, Validation, and Qualification and report preparation.
Validation Exposure
- Microbial limit test (MLT) method validation for Raw material, bulk samples, and finished product.
- Water system validation.
- Establishment of hold studies and the periodic microbial monitoring of sterilized garments, and other testing articles.
- Area qualification.
- Media shelf-life Validation.
- Disinfectant validation.
- Performance verification of LAFs.
- HVAC validation.
- Microbiology Equipment Qualification.
Personal Contributions
- Successfully completed USFDA and MHRA.
- Involved in several Audits like USFDA, MHRA, WHO, ANVISA, GCC.
- I had interacted with audit members which gave me great Experience.
- I had also faced several audits in the department where I learned all the phases of audit.
- I had undergone internal GMP & GLP training programs.
- Ability to grasp new ideas and integrate them into desired results.
Audit Achievements
- Successfully participations in 3 times of USFDA Auditing as a Microbiology team member in Hospira Healthcare India Pvt. Ltd.
- Successfully participated in 1 time of USFDA Audit, 2 times of FUMIA Auditing as a Microbiology team lead, and explained daily LIMS function in Aurobindo Pharma Ltd.
- Successfully participated in 1 time of USFDA Audit Auditing as a Microbiology Assist. Manager and explanation daily LIMS function in Venkata Narayana Active Ingredients Private Limited.
- Internal and external auditing shall be working as a co-auditor.
- External lab auditing and qualification of the lab. (VIMTA, SIGMA).
Disclaimer
I hereby declare that all particulars made in this application are true and right to the best of my knowledge.
Timeline
Assistant Manager
Bharat Biotech International Limited
07.2023 - Current
Assistant Manager
Ichor Biologics Pvt.Ltd
04.2022 - 05.2023
Deputy Manager
Kimia Biosciences Ltd.
11.2020 - 01.2022
Team leader
Venkata Narayana Active Ingredient pvt.ltd
11.2018 - 12.2019
Sr. Executive
Aurobindo Pharma
10.2015 - 06.2018
Executive
Hospira Healthcare India Pvt.Ltd
12.2011 - 09.2015
Trainee Executive
Doctors Life Sciences Pvt. Ltd
06.2011 - 12.2011
MS/M.Sc. - Microbiology
Acharya Nagarjuna University
B.Sc - Biology
Sri Venkateshwara University (SVU)