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Senior validation specialist skills for your resume and career

Updated January 8, 2025
5 min read
Below we've compiled a list of the most critical senior validation specialist skills. We ranked the top skills for senior validation specialists based on the percentage of resumes they appeared on. For example, 9.4% of senior validation specialist resumes contained gmp as a skill. Continue reading to find out what skills a senior validation specialist needs to be successful in the workplace.

15 senior 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.

Here's how senior validation specialists use gmp:
  • Coordinated validation related activities in regards to equipment and processes being deployed in GMP environments.
  • Validated CRMS in accordance with 21 CFR Part 11 and GMP regulations.

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.

Here's how senior validation specialists use fda:
  • Conducted regulatory audits for compliance with applicable FDA regulations for major pharmaceutical, industry-related and software development companies.
  • Monitor FDA and Industry organizations for changes and guidance on regulatory compliance for execution of validation activities.

3. 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.

Here's how senior validation specialists use qc:
  • Provided support to Manati QC Dept in order to troubleshoot analytical method reliability.
  • Task includes QC lot release/stability data package review, deviation management, troubleshooting, identify and implement improvement to existing assays.

4. Laboratory Equipment

Here's how senior validation specialists use laboratory equipment:
  • Installed and validated all laboratory equipment in Quality and Development Labs.
  • Review and approve Qualification documents for Laboratory Equipment.

5. QA

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.

Here's how senior validation specialists use qa:
  • Performed qualification of critical QA Micro-Lab equipment and Test Methods transferred from other sites.
  • Support QA Leadership in validation matters, site audits and site tactical matters.

6. Validation Studies

Here's how senior validation specialists use validation studies:
  • Reviewed and approved Protocols and Reports for Process and Cleaning Validation studies.
  • Performed cleaning validation studies for process equipment used to manufacture PDP-6 tablets.

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7. HVAC

Here's how senior validation specialists use hvac:
  • Execute Commissioning Protocols (IV and OV) for a HVAC system.
  • Designed Testing Standards for HVAC Computerized Systems.

8. Regulatory Compliance

Here's how senior validation specialists use regulatory compliance:
  • Ensured performance and quality of products conform to established company and regulatory compliance standards.
  • Assessed computer-related systems for regulatory compliance.

9. Process Validation

Process validation refers to the accumulation and analysis of data, starting from the process design stage to production, which provides scientific evidence that the process can routinely deliver quality products. To develop an effective process validation strategy, you need to ensure that each of its three stages has been properly taken care of. The first stage is process design, where the processes are defined. The second stage is process qualification, where the process, which has been designed earlier, is evaluated to make sure it can reproduce reliable and consistent levels of quality. The final stage is continued process verification that involves ongoing validation to ensure the process is under control.

Here's how senior validation specialists use process validation:
  • Performed validation of facilities/process equipment, cleaning validation, process validation, laboratory instruments and analysis, and process/method development.
  • Provide support to the Process Validation by developing and executing Experimental, Registration, Clinical and Process Protocols/Reports.

10. WFI

Here's how senior validation specialists use wfi:
  • Performed Project Manager functions for validation of Purified Water Systems; including DI, WFI, and Clean Steam systems.

11. Cleaning Validation

Here's how senior validation specialists use cleaning validation:
  • Performed Process Performance Qualification for new products and assisted in performing Cleaning Validation for product contact equipment.
  • Prepare documentation Product Contact and Equipment Surface Area for Manufacturing and Filling for Cleaning Validation Program.

12. Delta

Here's how senior validation specialists use delta:
  • Prepare a Project Plan for the testing activities required as part of the PR5 Delta V Fermentation/Utilities Areas screens upgrade project.
  • Develop Test Cases for the Fermentation and Utilities Areas screens being changed as part of the PR5 Delta V Upgrade Project.

13. Microbiology

Here's how senior validation specialists use microbiology:
  • Performed approvals for Microbiology Identification Laboratory analysis reports.
  • Scheduled and coordinated experimental and validation with personnel in planning, manufacturing, microbiology laboratories, and chemical laboratories.

14. IQ/OQ/PQ

Here's how senior validation specialists use iq/oq/pq:
  • Prepared and executed IQ/OQ/PQ Protocols for Computer System Validations.
  • Prepared Equipment/Process Qualification Protocols/Reports (IQ/OQ/PQ).

15. Risk Assessments

The process of analyzing and identifying the acts or events that have the potential to negatively affect an individual, asset, or business is called risk assessment. Risk assessments are important because they form an integral part of an organization as well as occupational safety plans

Here's how senior validation specialists use risk assessments:
  • Developed and executed test plans and risk assessments to resolve OOT, ER, Change Control and Work Orders.
  • Performed risk assessments as needed.
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List of senior validation specialist skills to add to your resume

The most important skills for a senior validation specialist resume and required skills for a senior validation specialist to have include:

  • GMP
  • FDA
  • QC
  • Laboratory Equipment
  • QA
  • Validation Studies
  • HVAC
  • Regulatory Compliance
  • Process Validation
  • WFI
  • Cleaning Validation
  • Delta
  • Microbiology
  • IQ/OQ/PQ
  • Risk Assessments
  • Iq Oq Pq
  • Summary Reports
  • R
  • CAPA
  • Pharmaceutical Industry
  • CIP
  • Computer System
  • Technical Support
  • CSV
  • URS
  • Autoclaves
  • System Validation
  • Process Equipment
  • Validation Projects
  • PLC
  • Validation Program
  • USP
  • ISO
  • Control Systems
  • TrackWise
  • Analytical Methods
  • Test Scripts
  • PR
  • IOQ
  • Traceability Matrix
  • Building Management System
  • Utility Systems
  • Equipment Validation
  • Dosage Forms
  • Environmental Monitoring
  • Deviation Reports
  • Test Cases
  • Water Systems

Updated January 8, 2025

Zippia Research Team
Zippia Team

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

Updated January 8, 2025

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