Skills
Process Validation
PPQ
Continuous Process Verification
CPV
Data harvesting
Statistical analysis
Control charts
Minitab
Microsoft Excel
Microsoft Office
Microsoft Word
Chemistry masters
Review and approval
Trackwise
Documentum
EDMS
Qumas
Change Control
About
As a detail-oriented and passionate pharmaceutical professional with extensive experience in process validation and statistical analysis, I bring a meticulous and data-driven approach to ensuring high-quality outcomes in the pharmaceutical industry. My strong background in Continuous Process Verification (CPV) allows me to excel at gathering and analysing critical data, performing a range of statistical tests, and graphically representing large datasets using tools like Minitab.
Key Skills and Expertise:
• Process Validation: Validating complex processes to ensure compliance with regulatory standards and enhance operational efficiency.
• Statistical Analysis: Proficient in statistical methods including control indices, T tests, Pearson’s correlation, and more, with experience in interpreting control charts using Nelson trending rules.
• Data Visualization: Creating graphical representations of data, such as box plots and control charts, to identify trends and inform decision-making.
• Cross-Functional Collaboration: Working with diverse teams to execute projects, provide training in statistics, and identify product trends.
• Quality Assurance: Experience in QA review and approvals of documentation related to equipment and process validation.
Experience Highlights:
• Thermo Fisher Scientific: Led the CPV program for several years, performing data collection and statistical analysis for critical performance parameters and quality attributes.
• Porton Biopharma Ltd: Gained valuable experience in fully paper-based validations and worked on the intricate manufacturing process of the orphan drug Erwinase. Successfully collaborated with stakeholders to present statistical analyses and process stability insights.
• Catalent Pharma Solutions: Played a key role in implementing and improving the CPV process, from data harvesting to the use of advanced tools like LIMs and Business Objects. Authored protocols and reports for various validation projects and introduced innovative methods for data analysis and visualization. Successfully completed major projects, including PV and PPQ, as well as iterative improvements to the CPV process.
Interest in Remote Work: I am seeking a remote work environment. I have successfully worked remotely in previous roles, demonstrating my ability to collaborate effectively and deliver high-quality results.
Profile Photo
