...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...
...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.
~ Basic technical presentations
~ Personal Organization
~ Validation Protocol Writing
~ Dealing...
...to learn more about our services and solutions!
Job Description
CSV consultant to evaluate laboratory equipment's CSV protocols for a pharma-biotech industry.
Qualifications
Bachelor’s degree in science & 5 years of experience in laboratory CSV....
...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...
...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....
...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...
...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...
...processes and procedures.
Develop Software/Computer Validation Protocols according to BMS policies on computerized systems validations.... ...software, as determined from the test performed on the protocol.
Analyzes data in order to determine acceptability. Recommends...
....
# 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...
...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...
...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...
...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...
...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...
...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....
...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...
...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...
...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...
...interact with all levels throughout the organization.
Functions:
~Review and approve product MPs.
~Approve process validation protocols and reports for manufacturing processes.
~Request Quality on incident triage team.
~Approve Environmental Characterization...
...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...
...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...
...Qualification/Validation documents, as applicable, following established standards and templates, including:
~Commissioning Forms
~C/Q/V Protocols and Summary Reports
~Standard Operating Procedures
~Impact/Risk Assessments
~Specifications (URS/FRS/DS)
~Electronic...
...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...
...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...
...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...