Anjana Janardhanan
Summary
Dedicated and results-oriented professional with experience in maintaining robust contamination and cleanliness control strategies. Skilled in optimizing cleanroom environments, and procedures, and enforcing strict hygiene protocols. Experienced in analyzing monitoring data, investigating issues, and implementing corrective actions to ensure compliance with industry regulations and drive continuous improvement.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Microbiologist 2
Glaxo Wellcome Manufacturing Pte Ltd
08.2024 - Current
- Supervising and managing a team of microbiology Analyst, and other laboratory staff.
- Planning and organizing laboratory activities and resources.
- Oversee environmental monitoring programs to assess microbial presence and identify potential contamination risks.
- Conduct microbial risk assessments for new products and facility modifications to ensure product safety and quality.
- Collaborate with cross-functional teams to develop innovative solutions for microbiological challenges.
- Ensure compliance with industry standards, regulations, and good manufacturing practices (GMP).
- Conducted gap assessments against pharmacopeia standards to ensure compliance.
- Lead investigations into contamination incidents, identify root cause, and implement corrective actions to prevent recurrence.
Senior Microbiologist and QMS
Biotronik APM Pte Ltd
04.2018 - 08.2024
- SME for Hygiene and Contamination control,Implement stringent contamination and cleanliness standards, consistently improve cleanroom procedures, and analyze monitoring data to proactively address potential issues.
- Participated in the qualification of the Cleanroom and utilities for the new production facility.
- Identified root causes of contamination incidents, implementing corrective actions to prevent future occurrences.
- Streamlined communication between departments by serving as a liaison between microbiology teams and other functional areas within the company.
- Manage regular microbiological assessments, including environmental monitoring, endotoxin testing, and bioburden testing.
- Develop and documents various microbiology laboratory processes and prepare final reports.Writing and executing validation protocols
- Maintain equipment inventories and order laboratory consumables as required and ensure equipment calibrations are performed in timely manner.
- Drive continuous improvement of environmental controls, work on improvement projects and validation as assigned
- Maintains Knowledge of GMP, ISO standards and regulatory requirement.
- Train, mentor and provide guidance to the reporting technician and interns
- Supported site Quality management representative to ensure the compliance of QMS towards applicable medical devices regulations and standards, in area of QMS processes such as Audits, CAPA, Change Control Management, Documentation/ Records Management and Training.
- Successfully implemented the QMS system integration with the System House.
Microbiologist
Beacons Pharmaceuticals
09.2017 - 04.2018
- Conducted microbiological testing, including environmental monitoring, bioburden testing, and endotoxin testing.
- Analyzed microbiological data to identify trends, assess product quality, and ensure regulatory compliance.
- Developed and implemented quality control procedures to prevent microbial contamination.
- Investigated and resolved quality issues related to microbial contamination.
- Contributed to the development and validation of new microbiological testing methods.
- Ensured compliance with relevant regulatory requirements.
- Maintained accurate and detailed records of microbiological testing and results.
- Provided technical support to other departments regarding microbiological issues and concerns.
- Contributed to continuous improvement initiatives to enhance microbiological practices and processes.
QA Laboratory Specialist
Tobacco
03.2013 - 05.2017
- Performs the efficient workload day-to-day laboratory activities; routinely inspect and audit the lab equipment to ensure calibration, and reports problems or concerns
- Tests samples to determine their adherence to specifications using GC and smoking machine
- Monitors supplies, tracks inventory, and performs order requests for lab supplies and equipment to ensure adequate supplies are available
- Performs and participates in lab maintenance, such as performing preventative maintenance as required, and diagnosing and troubleshooting lab equipment maintenance related issues
- Participates in the Quality Assurance/ Quality Control (QA/ QC) Lab processes and procedures, operation of lab equipment, sampling, and testing protocols
- Compliance with all Environmental, Health & Safety programs, policies, procedures, and regulations to support a safe working environment
- Maintain knowledge of Laboratory Information Management System (LIMS) that is required to complete job responsibilities
- Performed all other job responsibilities as required to ensure smooth operation of the laboratory
Education
Master of Science - Microbiology
University of Calicut
01.2004
Bachelor of Science - Microbiology
Kannur University
01.2001
Skills
- Microbiological and Analytical Testing
- Contamination Control
- Environmental monitoring
- Data Analysis and Technical writing
Certification
CQI and IRCA Certified Medical Devices - Quality Management Systems Auditor/Lead Auditor (ISO 13485:2016), ENR-01419949
Languages
English
Timeline
Microbiologist 2
Glaxo Wellcome Manufacturing Pte Ltd
08.2024 - Current
Senior Microbiologist and QMS
Biotronik APM Pte Ltd
04.2018 - 08.2024
Microbiologist
Beacons Pharmaceuticals
09.2017 - 04.2018
QA Laboratory Specialist
Tobacco
03.2013 - 05.2017
Bachelor of Science - Microbiology
Kannur University
Master of Science - Microbiology
University of Calicut
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