Resultados de la búsqueda: 48 vacantes
...ensuring accurate and detailed records are maintained for future reference and analysis.
~ Adhere strictly to all procedures and protocols, ensuring compliance with regulatory standards and company policies at all times.
Qualifications Requirements/Knowledge/...
...AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes.
Request Quality on incident triage team.
Approve Environmental Characterization reports...
...and applied engineering.
• Basic technical report writing
• Verbal communication
• Comprehensive understanding of validation protocol execution requirements.
• Demonstrated Skills in the following areas:
• Basic technical presentations
• Personal...
...and applied engineering.
~ Basic technical report writing
~ Verbal communication
~ Comprehensive understanding of validation protocol execution requirements.
~ Basic technical presentations
~ Personal Organization
~ Validation Protocol Writing
~ Dealing...
...Characterization
Design / Development of Characterization Protocols
Validations, technical reports and p rotocol writing... ...that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.
Designs, monitors...
...Testing Strategies
Design / Development of Characterization Protocols
Technical Reports Development
Validations, and technical... ...limited scope.
Comprehensive understanding of validation protocol execution requirements. In-depth knowledge of validation processes...
...manufacturing industry in Puerto Rico & USA.
Responsibilities:
Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes.
Request Quality on incident triage team.
Approve Environmental Characterization...
....
# Minimum two (2) years of direct related experience in laboratory method development,validation, cleaning methods validation protocols and analytical technologytransfer.
# Experience in a cGMP regulated analytical laboratory and previous participation in method development...
...in support of site Quality Assurance program under minimal supervision. Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports....
...Provides input to new processes to generate robust and reliable data. I would like to assure you that studies comply with the respective protocol and applicable guidelines and regulations. Designs, monitors, or conducts experimental strategies with general guidance from the...
...among others. Coordinates the logistics and resources needed to perform the work successfully, following applicable codes, standards, protocols, and processes. Performs preventive maintenance work on electrical equipment and systems to ensure an effective operation. Each...
...project or entirety of smaller project.
~ Ability to interpret and apply GLPs and GMPs.
~ Comprehensive understanding of validation protocol execution requirements.
~In-depth knowledge of validation processes and requirements as applied to new equipment installations....
...production. 21. Able to develop solutions to routine technical problems of limited scope. 22. Comprehensive understanding of validation protocol execution and knowledge of validation processes as applied to new equipment installations. 23. Skills in the following areas:...
...Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements
• Validated experience as Quality...
...Testing Strategies
o Design / Development of Characterization Protocols
o Technical Reports Development
o Validations, and... ...scope.
• Comprehensive understanding of validation protocol execution requirements. In-depth knowledge of validation processes...
..., as well as the involved project management.
Job Description
Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes.
Represent Quality on incident triage team.
Approve Environmental Characterization reports...
...directly related to production areas.
Technical writing experiences related to complex investigations of manufacturing processes and protocols.
Experience in deviation management, troubleshooting and resolving manufacturing trends.
Experienced with formal problem...
...input to new processes to generate robust and reliable data. Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.
Responsibilities:
Designs, monitors or conducts experimental strategies with general...
...corrective actions.
Responsible for managing NC/CAPA closure within established goal.
Assist with generation of process validation protocols and reports.
Participate in the NPI process to assess requirements for documentation, materials, training, and equipment...
...manufacturing industry in Puerto Rico & USA.
Responsibilities:
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing...