Validation Specialist Resume Orlando, FL - Hire IT People

SUMMARY

PROFESSIONAL EXPERIENCE

Validation Specialist

Confidential, Orlando, FL

Responsibilities:

In charge of Project Development and Management of Validation activities.
Research and analyze data to determine whether systems of processes have met acceptance criteria.
Provide statistical analysis to determine Process Capability and Process Improvement.
Conduct audits and investigations of manufacturing processes to identify root cause or deficiencies, and implement corrective actions.
Design and provide training for multidisciplinary departments for validation protocol execution and continuous improvement projects.
Review and update Standard Operating Procedures, Calibrations, Master Validation Plans, Master Batch Records and Validation documentation.
Develop, maintain and implement Cleaning Validation Master Plan and validations.
Challenge manufacturing process critical parameters to validate implemented changes.
Develop and manage the Installation, Operational and Performance Qualification of Manufacturing and Packaging equipment.

Senior Scientist

Confidential

Responsibilities:

In charge of Quality Assurance and Validation activities in different pharmaceutical and biotechnology manufacturing facilities.
Develop Clean Room Re-Classification ISO Certification strategy for biotechnology facility.
Perform Cleaning In Place and Steam In Place validations for biotechnology manufacturing equipment.

Confidential

Microbiology Specialist

Responsibilities:

In charge of evaluation of changes in processes for Microbiology Validations.
Manage all Microbiology Validations fortransferred productsand Environmental Program.
Review and manage data for final reports.
Participate as Quality Assurance for Batch Record Review.
Develop procedures for Environmental samples for Microbiology.

Occupational Health and Safety Specialist

Confidential, Dorado, PR

Responsibilities:

In charge of support Occupational Health and Safety Department in a pharmaceutical manufacturing facility.
Search and identify biological, physical and chemical hazards.
Perform safety / health exposure monitoring and personal protective equipment assessments. Collect and analyze data in final reports, including actions to be taken.
Design and conduct EHS inspections / audits and hazard assessments of cleanrooms, laboratories, and facility areas to identify risks.
In charge of Product and Technology Transfer between facilities.
Perform tests for raw materials, and summarize final reports.
Support activities for Stability Studies.

Confidential

Microbiology Specialist

Responsibilities:

In charge of Quality Assurance operations relatedto microbiology raw materials / productrequirements.
Manage trend data analysis of microbiology historical data to develop environmental program.
Review Batch Records for microbiology and audits compliance.
Submit, receive, review and approve alltests received form Microbiology laboratory (environment, raw materials, finished product).
Design andcollection ofsamples required for microbiology validations.
Conduct investigations after alert and / or action limits results.
Develop action plans after investigations; train personnel for implementation.