KRISHNA OZA
Summary
High-energy, detail-oriented Quality assurance/Quality control Associate with more than 5 years of progressive experience in the pharmaceutical industry. Ability to keep punctilious records. Knowledgeable and competent in cGMP and maintaining an effective Quality Maintaining Systems, with all actions and decisions governed by ensuring patient safety, and product quality and efficacy. Self motivated to learn, grow and excel in the pharmaceutical industry.
Overview
2010
2010
years of professional experience
Work History
Quality Assurance and Quality Control
Raritan Pharmaceutical
- Responsible for ensuring accuracy and integrity of all data reported from microbiology department
- Review all raw data and associated documentation cGMP, GDP and regulatory conformance, as well as to Glenmark SOPs and specifications
- Facilitate data and documentation corrections with microbiologist to ensure all records are complete and appropriate references are made
- Ensure investigations, excursions are assigned as applicable, completed and referenced for data as appropriate prior to release of microbiology data
- Review of laboratory notebooks, log books and other source data (e.g. printouts, executed forms, etc.) for completeness, and archival, as appropriate
- Interact with Quality management as needed and all team members to identify and aid in the implementation of GDP, security, integrity or efficiency improvements
- Assist in the investigation and review of deviation reports and OOS reports to assure complete and compliance data
- Assist in training and mentoring junior analyst on the interpretation of data and use of electronic data system
- Other duties as identified by direct supervisor
- Quality Control for Labels, Cartons and Stickers
- Quality assurance for document control for all aspects of GMP, GCP GLP.
- Compare the approved labels and cartons and release them in a timely manner.
- Identify any deviation or errors and report to the supervisor.
Certified Pharmacy Technician
CVS Pharmacy
Clinical Research Associate
Clianta Research
01.2009 - 01.2010
- Company Overview: AHMEDABAD, INDIA
- Determined the logistics of each drug trial, handled investigator selection, and patient selection duties.
- Prepared trial related documentation including case report forms and consent documents.
- Organized startup meetings and study site initiation conferences.
- Coordinated the movement of laboratory samples, and ensured that procedures are set for optimization of patients into the trial.
- Planned requirements for clinical trial materials, set up and monitor systems, and maintain procedures to account for trial materials.
- Developed study tools and guides for each clinical trial.
- Interacted with field monitors to ensure appropriate management of study issues.
- Coordinated activities at investigational sites.
- Conducted co-monitoring visits and reviewed monitoring trip reports.
- Assisted in the development of study timelines and priorities.
- AHMEDABAD, INDIA
- Clinical Research Skills
- Trial Methodologies
- Trail Study Center Setup
- Data Collection
- Protocols Development
- Integrated Medical Reports
- Protocol Adherence
Education
Bachelor of Pharmacy -
L.M. College of Pharmacy
01.1990
Diploma - system Analysis
Silver line
Bombay01.1998
Certificates - computer education
APTECH
01.1999
Intel Master Training course -
Government of Gujarat
01.2005
Certified clinical research associate -
ACEAS and ICRI
U.K.01.2006
Certificate of Pharmacy Technician -
NABP
USA01.2012
Advanced clinical research course -
Sollers
NJ, USA01.2014
Drug safety associate course -
Qtech
NJ, USA01.2020
Skills
- Trial Methodologies
- Trail Study Center Setup
- Data Collection
- Protocols Development
- Integrated Medical Reports
- Protocol Adherence
- Microsoft office & power point
- LINUX
- WINDOWS based projects
Clinical Research Skills
- Trial Methodologies
- Trial Study Center Setup
- Data Collection
- Protocols Development
- Integrated Medical Reports
- Protocol Adherence
Timeline
Clinical Research Associate
Clianta Research
01.2009 - 01.2010
Bachelor of Pharmacy -
L.M. College of Pharmacy
Diploma - system Analysis
Silver line
Certificates - computer education
APTECH
Intel Master Training course -
Government of Gujarat
Certified clinical research associate -
ACEAS and ICRI
Certificate of Pharmacy Technician -
NABP
Advanced clinical research course -
Sollers
Drug safety associate course -
Qtech
Quality Assurance and Quality Control
Raritan Pharmaceutical
Certified Pharmacy Technician
CVS Pharmacy
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