...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...
...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...
...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...
...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...
...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...
...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....
...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...
...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...
...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:...
...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...
...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...
...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...
...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...
...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...
...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...
...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....
...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...
...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...
...and applied engineering.
~ Basic technical report writing.
~ Verbal communication
~ Comprehensive understanding of validation protocol execution requirements.
~ Basic technical presentations.
~ Personal Organizationo Validation Protocol Writing.
~ Dealing...
...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...
...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...
...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...
...Technical Writing
- Organization
- Facilitation
- Dealing with and managing change
- Comprehensive understanding of validation protocol requirements
- Technical (Equipment Specific)
- Analytical Problem Solving
- Project Management & Planning
- Scheduling
-...
...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...
...AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Develops, modifies, applies, and maintains quality standards and protocols for processing materials into partially finished or finished materials products.
Collaborates with engineering and manufacturing...
...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...
...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...
...Project Management skills.
Shift: Administrative and according to business needs.
Experience in:
Documentation background (protocols, SOP, etc)
Commissioning & Qualification execution
The Personality Part:
~ If you value healthy competition, teamwork,...
...and applied engineering. o Basic technical report writing.
~ Verbal communication.
~ Comprehensive understanding of validation protocol execution requirements.
~ Demonstrated Skills in the following areas: basic technical presentations, personal Organization,...
$45 - $55 por hora
...analysis and submit recommendations, as required.
Perform inspections of programs/equipment operation following established execution protocols.
Manage the deliverables to agreed schedule and scope of work.
Maintain excellent communications with upper management and...