Ammu Godwin
Dublin
Summary
Comprehensively trained in Lean Six Sigma with Green Belt, PAT, and regulatory affairs in NIBRT, Ireland. Experienced using SAP, DMS and LIMS. Accomplished Problem-Solving Risk Analysis using - FMEA, DOE, and Root cause Analysis. Cell culture skills using: T-cells, CHO cells, Plant tissues. Molecular Analysis: PCR, Gel Electrophoresis, SDS-PAGE, ELISA, DNA/Protein Purification, Immuno-Assays. Computational: Microsoft 365, NCBI, ANOVA Model. Strong knowledge of Biopharmaceutical Manufacturing, Upstream, and Downstream Processes. Communicative and team-oriented with proficiency in Planning and Execution. Proven history of fostering leadership to meet team, individual, and management objectives.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Quality Assurance Analyst
Grifols World Wide Operations
Dublin, Ireland
03.2023 - Current
- Developed and maintained quality assurance protocols, processes and procedures.
- Reviewing and approving SOP's, validation protocols and reports and other GMP documentation.
- Ensure that general cGMP programs are delivered and maintained effectively at GWWO.
- Lead and/participate in technical deviations, investigations, CAPA and change controls and provide Quality support to the manufacturing area.
- Performed root cause analysis of defects identified during testing cycles.
- Perform the spot check/ walk-through process of the area.
- Training of new Quality personnel where appropriate and development of new training.
QC Microbiology Analyst
Eurofins Environmental Testing
Dublin
09.2021 - Current
- Documentation and data entry of final results into the Laboratory Information Management System (LIMS), Pathogen detection using cultural, ELISA, and PCR methods
- Bacterial enumeration using pour plate, spread plate, Petrifilm, and MPN methods
- Purified Water, Water for injection and Clean steam microbiological bioburden (TVC) and Endotoxin (LAL) analysis
- Also analytical testing including pH, Conductivity, Total Organic Carbon (TOC)
- Participated during INAB audits and internal audits from Eurofins Scientific
- Investigate Out of Specification (OOS) and Out of Trend (OOT) results as required.
Healthcare Advisor
Hickeys Pharmacy
Dublin
11.2024 - 09.2024
- Helped patients navigate the healthcare system and care options by educating them on relevant subject areas and answering questions throughout the treatment process
- Provided strategic business advice to healthcare startup companies and private equity investments
- Maintained knowledge of community services and resources and referred patients to appropriate organizations
- Educated patients and caregivers in the use of at-home healthcare equipment
- Worked successfully with a diverse group of coworkers to accomplish goals and address our products and service issues.
Intern
National Institute for Bioprocessing Research and Training
Dublin
01.2022 - 03.2022
- During this training, I came across an overall industrial experience that involved bioprocessing technologies such as upstream, downstream, and fill-finish operations, cell lines, and banking along with cell culture, ventilation cabinets bioreactor designing, and control, harvest, and single-use technologies
- I had an opportunity to work in filtration, chromatography (HPLC, LC-MS, GC) and also in virus clearance, fill-finish and Barrier technology, and lyophilization techniques
- Additionally, I also received training under the guidance of my trainers for the cleanroom designs and behaviors along with contamination control and maintenance
- Set up equipment and welded parts according to welding chart specifications and type
- Practice and implementation of safety profiles in the laboratory.
Industrial Manufacturing Intern
AR Industries
India
05.2017 - 12.2019
- As an Industrial intern, I had to test product samples for specific gravity, chemical characteristics, pH levels, concentrations, and viscosities
- Added neutralizing agents to products and pumped products through filters to remove impurities
- Checking calculation and critical steps along with investigating aberrant results
- Documenting all actions and decisions
- Separating the job of production and product disposition to assure objectivity
- I also had the opportunity to utilize batch logs, SOPs (Standard Operating Procedure) and work instructions under GMP guidelines.
Education
Master of Science - Biopharmaceutical Technology
Technological University of Shannon: Midland Midwest
Doctor of Pharmacy - Clinical Pharmacy
Kerala University of Health Sciences
Skills
- Correction action planning
- Risk Management
- Data Analysis
- Quality Management Systems
- Test results analysis
- Leadership
- Team building
- Proficient in SAP,ELIMS, DMS
- GMP skills
- Microsoft Expertise: Word, Excel & PowerPoint
Certification
Licensed for Training under Biopharmaceutical Processing, 30-5-2022, https://openbadgepassport.com/app/badge/info/456336
Timeline
Healthcare Advisor
Hickeys Pharmacy
11.2024 - 09.2024
Quality Assurance Analyst
Grifols World Wide Operations
03.2023 - Current
Intern
National Institute for Bioprocessing Research and Training
01.2022 - 03.2022
QC Microbiology Analyst
Eurofins Environmental Testing
09.2021 - Current
Industrial Manufacturing Intern
AR Industries
05.2017 - 12.2019
Master of Science - Biopharmaceutical Technology
Technological University of Shannon: Midland Midwest
Doctor of Pharmacy - Clinical Pharmacy
Kerala University of Health Sciences
Similar Profiles
MARK JOSEPH MEDIANAMARK JOSEPH MEDIANA
Counter Sales Representative at Wide Wide World Express Corporation - PascorCounter Sales Representative at Wide Wide World Express Corporation - Pascor
Brandon AlexanderBrandon Alexander
Warehouse Specialist at World Wide Technology, Inc.Warehouse Specialist at World Wide Technology, Inc.
OLUWADAMILOLA ADESOLA OLANIYIOLUWADAMILOLA ADESOLA OLANIYI
Child Youth Support Worker at Famous Care World WIdeChild Youth Support Worker at Famous Care World WIde