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Validation specialist skills for your resume and career
15 validation specialist skills for your resume and career
1. GMP
GMP stands for Good Manufacturing Practice. It is a system that ensures that all products like food, beverages, and medicinal drugs that are produced comply with the quality standards. It helps in minimizing the risks and hazards that cannot be eliminated after the testing of final products.
- Involved in preparing GMP Assessments, 21CFR11 Assessments, and Risk Analysis, on seventeen PLC & PC based systems.
- Identify errors in software used to store Good Manufacturing Practices (GMP) generated data and calculate experimental results.
2. FDA
The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.
- Examined and documented pharmaceutical manufacturing lines for adherence to FDA guidelines; developed operating manuals for industrial manufacturing lines and machinery.
- Supported various quality systems related to validation execution to ensure timely closure of final reports related to FDA consent decree.
3. IQ/OQ/PQ
- Developed commissioning protocols and validation IQ/OQ/PQ protocols for fermentation and cell culture population.
- Performed IQ/OQ/PQ on laboratory and manufacturing equipment.
4. Iq Oq Pq
- Execute IQ OQ PQ protocols and work with customer validation experts.
5. Summary Reports
Summary reports contain essential information from different operations, often organized through graphs and charts. Most summary reports are short and precise, containing highlights, conclusions, and even recommendations.
- Developed commissioning and qualification documents such as Impact Assessments, User Requirements, Commissioning Protocols, Commissioning Checklists and Summary Reports.
- Experience in the development and execution of Commissioning and Qualification Protocols, deviations and Protocol Summary Reports in the Pharmaceutical Industry.
6. Laboratory Equipment
- Reviewed and approved Computer Software Validation projects for laboratory equipment and automated systems; verified LIMS and CDAS systems.
- Obtained data and generated the necessary documentation to incorporate laboratory equipment in the Calibration and Preventive Maintenance program.
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QA, or Quality Assurance is a procedure that entails all of the steps taken to avoid any errors in the manufacturing process or in the production of the goods that a company produces. It can also include ensuring the consistency of the services rendered. Quality assurance ensures that the quality of the service delivered to consumers meets or exceeds the promised expectations. This greatly aids in the prevention of any complications that might arise after the goods or services have been distributed. It makes sure that customers are satisfied.
- Managed all cleaning validation schedule and coordinated activities with QA and/or external laboratories and operations.
- Interacted with QA, Engineering and Manufacturing personnel to coordinate validation activities.
8. Cleaning Validation
- Coordinate cleaning validation execution activities with supporting areas such as laboratories and operations supervisors and collect samples during cleaning validation activities.
- Supported the cleaning validation activities by executing cleaning checklists, performing investigations related to protocol deviations, and generating final reports.
9. Computer System
- Participated in the interpretation of computer systems regulatory requirements and provide guidance in computer systems validation strategy for PAT instruments qualification.
- Assisted other project team members in validation activities while interfacing lab equipment and analyzers through Computer System Validation.
10. CSV
- Developed and/or executed CSV Installations and Operational Qualification Protocols for laboratory instruments.
- Performed IQ, OQ, and PQ for the qualification of HVAC Mechanical systems and CSV in a regulated manufacturing facility.
11. Process Equipment
Process equipment refers to the machinery used in processing and refining industries. This equipment is responsible for a single job in the refinement process, which can vary from maintaining the flow of a chemical, controlling chemical reactions, or even storing chemicals. Process equipment can also be broken down into two categories, which are fixed and rotating equipment, depending on the movement required from the equipment.
- Performed calibrations on measuring and recording devices for critical utilities and process equipment.
- Develop protocols for process equipment used to perform various batch applications.
12. QC
Quality control is a set of instructions or procedures to ensure a manufactured product or a service is up to the highest quality standards. This set of quality control criteria are either defined by the clients or the company itself.
- Provided QC review and approval of software validation documentation.
- Conducted browser compatibility test of application * Reported the bugs, Email notifications to the developers using the QC.
13. HVAC
- Prepare reports binders for Installation Qualification Protocols and Operation Qualification Programs for HVAC Systems.
- Executed successful HVAC system qualification for several clients in new and renovated processing facilities.
14. System Validation
- Supervised the Computerized System Validation cycle and implemented best practices associated with protocols and execution.
- Represented system validation and documentation of testing during client audits.
15. Autoclaves
- General Responsibilities: Performed initial qualifications and periodic re-qualifications of f autoclaves, Filling lines, glassware washers.
- Generated and executed performance qualification protocols including data analysis on multiple autoclaves by multiple manufacturers.
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List of validation specialist skills to add to your resume
The most important skills for a validation specialist resume and required skills for a validation specialist to have include:
- GMP
- FDA
- IQ/OQ/PQ
- Iq Oq Pq
- Summary Reports
- Laboratory Equipment
- QA
- Cleaning Validation
- Computer System
- CSV
- Process Equipment
- QC
- HVAC
- System Validation
- Autoclaves
- Risk Assessments
- Lifecycle Management
- Corrective Action
- GxP
- Acceptance Criteria
- R
- Test Scripts
- CAPA
- URS
- Management System
- Technical Support
- Pharmaceutical Industry
- Validation Process
- ISO
- CIP
- Equipment Validation
- Validation Studies
- Data Analysis
- PLC
- Validation Projects
- Incubators
- Lims
- Kaye Validator
- FMEA
- Test Results
- USP
- Traceability Matrix
- TrackWise
- Design Specifications
- Test Cases
- IOQ
- PR
- Validation Reports
- Control Systems
- SDLC
Updated January 8, 2025