...Qualifications:
Knowledge and experience working with Change Controls on trackwise. (Prefer experience that we are looking).... ...styles.
~Ability to independently determine when additional internal resources are required to solve problems.
~ Ability to handle...
Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico .
Description:
Independently provides and/or directs the characterization...
...Cost Control services in the Capital Projects area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor's Degree and eight (8) year of exposure in project experience.
Bilingual (English & Spanish).
Project Management skills.
Shift: Administrative and according...
...standards and FDA standards.
Comp etencies / Skills:
Background in programming, installation of manufacturing process controls, automation and field instrumentation technologies.
Knowledge on Rockwell Automation Platform and Allen-Bradley PLCs, Rockwell...
...according to business needs.
Experience in:
Supplier change control
PPAP Activities
SAP System
Medical Devices.
The... ...(GMP) and quality standards.
~ Evaluates suppliers' internal functions to assess their overall performance and provides feedback...
...management of quality, compliance, supply and safety risks
• Supports internal/external audits and inspections as part of the audit/inspection... ...in Quality Systems such as Non-Conformance, CAPA, and Change Control
• Experience in computer systems validation or computer...
...practices (GMP) and quality standards are met.
Evaluates suppliers' internal functions to assess their overall performance and provides... ...-functional team.
~ Ability to understand Supplier Change control process.
~ Manage PPAP activities
~1st shift availability...
...lifecycle management of manufacturing process controls, automation and field instrumentation... ...and creativity. 16. Develop process control applications utilizing Programmable Logic... ...independently determine when additional internal resources are needed to solve problems and...
...Qualifications
~Knowledge and experience working with Change Controls on trackwise. (Prefer experience that we are looking)
~ Knowledge... ...styles
~ Ability to independently determine when additional internal resources are required to solve problems
~Ability to handle...
...:
Bachelor’s Degree in Electrical / controls / software Engineering with over five... ....
Implement new systems. Coordinates internal and external resources.
Assist in the... ...the programming, electromechanical and control features of custom automated systems, as...
...Ensure project work complies with domestic (may also involve international) regulatory requirements and approved guidelines relevant to... ...Knowledge using Track wise System managing specifically Change Controls (technical writing Spanish & English highly recommended).
~...
...work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple... ...holidays).
Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms.
No make...
...Ensure that documentation changes adhere to regulatory guidelines, internal quality standards, and industry best practices.
~Collaborate... ...to implement documentation changes efficiently.
~Pest Control Program:
~Provide support to the pest control program to maintain...
...Maintain the master project plan and schedule for assigned projects.
Ensure project work complies with domestic (may also involve international) regulatory requirements and approved guidelines relevant to area of responsibility.
Ensure project work complies with...
...• Interacts effectively with variety of communication and working styles
• Ability to independently determine when additional internal resources are required to solve problems
• Ability to handle multiple projects at one time
• Demonstrated Skills in the following...
...complex.
Makes minor changes in systems and processes to solve problems .
Communication and Influence: Communicates primarily with internal contacts within immediate group.
Contacts others to gather, confirm and convey information.
Leadership and Talent Management:...
...documentation in a highly regulated environment
Ability to learn, install, maintain, and troubleshoot relay logic, ladder diagrams, control components, photo eyes, motor starts, relays, limit switches, proximity sensors, timers, solenoids and frequency inverters....
...Specialist QA with experience in:
Aseptic Technics
Change Control
New Product Introduction
Requirements
Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience (Education...
...more about our services and solutions!
Job Description
Specialist QA with experience in:
Aseptic Technics
Change Control
New Product Introduction
Qualifications
Doctorate degree or Master's degree and 3 years of directly related experience...
...scientific or technical aspects of the process.
Process Monitoring
1. Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
2. Provide support of timely execution of the...
...of related SOPs for work related areas.
Configure and repair microprocessor-based instruments and controllers.
Basic troubleshooting and repair of process control and laboratory instruments.
All work must be completed in accordance with CFRs, cGMPs, SOPs, and policies...
...de realizar/proporcionar calibración, reparación, instalación, resolución de problemas y documentación de instrumentos, sistemas de control de procesos y equipos utilizados en la fabricación, plantas de servicios públicos y laboratorios analíticos. Para aplicar, visite...
...Project Management skills
Shift: Administrative and according to business needs.
Experience in:
Aseptic Technics
Change Control
New Product Introduction (NPI)
The Personality Part:
~ Being self-motivated means that you are curious, anxious to...
...the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipments, tools, or controls. The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and smell...
The Document Control performs a wide range of duties including the following:
Copy, scan and store documents
Check for accuracy... ...manuals and workflows)
Distribute project-related copies to internal team
File documents in physical and digital records
Create...
...for area within the project or entirety of smaller project
Experience to have
Knowledge and experience working with Change Controls on trackwise. (Prefer experience that we are looking)
• Knowledge in Packaging equipment.
• Knowledge in Design of new equipment...
...project teams to manage their projects and evaluate weekly reports.
Ensure accuracy of project schedules and performed version control.
Co-ordinate project schedules, tasks, meeting updates, and efficient distribution of reports.
Development and reporting of Project...
...Responsible for performing/providing calibration, repair, installation, troubleshooting, and documentation of instruments, process control systems, and equipment used in manufacturing, utility plants, and analytical labs.
Perform basic calibrations of instruments on...
...~Approve NC investigations and CAPA records.
~Approve change controls.
~Provide lot disposition and authorize lots for shipment.... ...MPs, MSRs) and identification of discrepancies.
~Participate in internal plant audits.
~Work with operations to resolve basic compliance...
...and clean room systems.
Knowledge, Skills, and Abilities
Background in programming, installation of manufacturing process controls, automation, and field instrumentation technologies.
Working knowledge of pharmaceutical/biotechnology processes.
Familiarity...