Resultados de la búsqueda: 51 vacantes
...requirements for documentation, materials, training, and equipment modifications.
Assist with generation of process validation protocols and reports.
Ensure that all Non-conformances are triaged within the established goal.
Responsible for managing NC/CAPA closure...
...equipment/system Root Cause Analysis investigations and support trend evaluations.
~ Assist with generation of process validation protocols and reports.
~ Assist with the execution of the process validation.
~ Support collection and analysis of process validation...
...GMP tasks.
Work with operations to resolve basic discrepancies
Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes.
Approve Environmental Characterizations reports.
Release of sanitary utility...
...AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing...
...internal team members.
~ Competency in managing NC/CAPA closure within established goals.
~ Experience generating process validation protocols and reports.
~ Assist manufacturing change owner on CCRB packages impacting the process.
~ Participate in the NPI process to...
..., 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...
...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...
...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. Designs, monitors or conducts experimental strategies with general guidance from supervisor...
...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...
...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...
...Cause Analysis investigations and support trend evaluations.
Process Validation
1. Assist with generation of process validation protocols and reports.
2. Assist with the execution of the process validation.
3. Support collection and analysis of process validation...
...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...
...Execute and/or approval of Process Validations and Qualifications
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing...
...Requirements:
Demonstrated understanding reviewing/writing technical documents, risk assessment reports, validation documents, IOQ protocols and final reports
Hands-on experience supporting/executing IQ, OQ (IOQ) equipment qualification related to various cleaning...
...function blocks and ladder diagrams
HMI: Wonderware and other applicable systems
Understanding of various industrial networks and protocols
Proficient on Modbus TCP, Profibus, CAN-bus, CIP, EtherNet/IP, DeviceNET, ControlNET, Industrial Ethernet
Advance...
...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:...
...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...
...solving and applied engineering.
o Basic technical report writing
Verbal communication
Comprehensive understanding of validation protocol execution requirements.
Demonstrated Skills in the following areas:
o Basic technical presentations
o Personal Organization...
...support of the 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...
