Resultados de la búsqueda: 56 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...
...ensure on time completion.
Supports the preparation of technical documentation related to the projects, including strategic plans, protocols, and reports.
Works with Operations, Support and Transactional areas to develop and maintain an end to end current and future...
...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...
...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...
...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...
...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...
...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...
..., 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...
...ensure on time completion.
Supports the preparation of technical documentation related to the projects, including strategic plans, protocols, and reports.
Works with Operations, Support and Transactional areas to develop and maintain an end to end current and future...
...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...
...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....
...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...
...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...
...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...
...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...
...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:...
...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...
...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...
