...are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
~Document Control Representative
The Document Control Representative will play a critical role in maintaining and organizing documents,...
...perspective.
Managing quality investigations, CAPA's, Pest Control, HVAC and utilities.
Documentation Support.
FDA regulations.
The Personality... ...and CAPA’s, audits. Work performed by the team is documented and recorded in the proper fashion.
~Sustain...
...Supports the Analytical Ruggedness Project Manager and Quality Control to gather information on investigations, troubleshooting, method... ...Provides timely and efficient technical reports to document all analytical improvement or investigation projects.
Evaluates...
...approach and Quality assurance direction to the approval of the GMP documents such as batch records, forms, protocols, procedures,... ...needed.
11. Manages audit observation, investigations, change control and CAPAs records in applicable QMS on timely manner.
12. Provides...
...interruptions or costly machine breakdowns.
Adhering to and documenting applicable preventive maintenance schedules in the Maximo... ...Monitor and operate HVAC systems to ensure proper functioning and controlled environmental conditions for facilities rooms, including,...
...manufacturing
Batch Record review and Protocol review
CAPA, Change Control and Annual Product Review
The Personality Part:
~... ....
~Leads and participates in the critical review of all documents associated with the manufacturing and/or support areas operations...
...#Supports the Analytical Ruggedness Project Manager and Quality Control to gather information on investigations, troubleshooting,... ...Instruments.
#Provides timely and efficient technical reports to document all analytical improvement or investigation projects.
#Evaluates...
...America.
Responsibilities:
Evaluates documentation compliance for all manufacturing and... ...protocols, Traceability Matrix document, and Validations reports among others.... ...validation protocols and reports, change control documentation, reprocessing / rework operations...
...Sterile/Biologics products.
~Responsibilities include the Interaction and support using the company standard packaging documentation change control system.
~This position must comply with all security guidelines, Environmental Health and Safety regulations and the current...
...material, tools, and equipment, required permits, specialized documentation and equipment access.
Compiles and maintains the Master... ...hands to finger, handle, feel, or operate equipment, tools, or controls. The employee frequently is required to stand, walk, talk, or...
...warranties for laboratory equipment and instruments.
# Manage documentation routing processes to ensure accuracy and compliance with... ...hands to finger, handle, feel, or operate equipment's, tools, or controls. The employee frequently is required to stand, walk, talk, or...
...The Technical Part:
Bachelor’s degree in engineering or science. • Training in validation methodologies, technologies and process control computer systems. • Five (5) years of experience in computerized system validation of pharmaceutical or biopharmaceutical industry....
...the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipment's, tools, or controls. The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and...
...electronico en oficina Prueba de Dopaje en oficina Adiestramientos antes de comenzar a trabajar parte del contrato Entrega de toda la documentacion y credenciales personales para ser contratado Usar uniformes asignados. SI CUMPLE CON ESTOS REQUISITOS FAVOR DE ENVIAR RESUMES A...
...environmental programs, focusing on recognizing, evaluating, and controlling environmental hazards.
~ Advice management on the proper... ...environmental sampling, reports monitoring results, and recommends control measures to management.
~ Oversight the operation of the...
...#Literacy of pharmaceutical industry analysis of Bulk Products and/or finished dosage forms.
#Knowledge of Statistical Process Control, and Design of Experiments with demonstrated analytical and problem-solving skills.
#Willing to work irregular hours, rotative shifts...
...decisions and developing recommendations. Limiting factors might include existing policies, procedures, laws, regulations, internal controls, etc.:
• The incumbent is responsible for the day-to-day decision making on technical matters related to troubleshooting,...
RESPONSIBILITIES
Accountable for timeliness statistical analysis and trending of product batch data to ensure process control and capability and; for product robustness analyses through the overseeing, coordination support, collection and monitoring of product batch information...
...to appropriate staff. Confirm reservations and cancellations. Review out-of-order rooms daily. Ensure rates match market codes and document exceptions. Verify and adjust billing for guests. File guest paperwork or documentation. Set up/process all guest check-ins/check-...
Marriott International
Dorado
3 días atrás
...overall inspection certification program, personnel certification, new inspection methodology, inspection test set maintenance and control.
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important...
...overall inspection certification program, personnel certification, new inspection methodology, inspection test set maintenance and control.
Minimum Requirements:
~Bachelor Degree in Sciences or Engineering (Mechanical, Electrical or Computer).
~Five (5) years in the...
...inventory that is damaged or expired) for safe transportation;
Interacting with customers at each stop;
Prepare DOT shipping documents;
Use of a laptop, printer, hand held, and iPhone to complete tasks;
Conduct projects/jobs according to site specific Federal...
Clean Harbors
Manatí
Hace 2 meses
...potential roadblocks and proactively resolves problems.
~Direct project correspondences by preparing and reviewing project proposals, memos, meeting minutes, change controls and emails; as applicable.
~Motivating people involved in the project to complete tasks on time....
...extended hours, possibility of weekends and holidays.
Responsibilities:
~OOS Lead Investigator for utilities, facilities and pest control
~Risk Assessment Review
~Site Deviations Support
~CAPA support
~SOP Revisions
~Forms optimization project
~Change Control /...
....
~Experience in pharmaceutical facilities and equipment qualifications in a manufacturing environment.
~Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
~SDLC, Risk Assessment, Data Integrity...
...cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
~Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
~SDLC, Risk Assessment, Data Integrity...
...cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
~Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
~SDLC, Risk Assessment, Data Integrity...
...experience in the Quality Assurance in the industry.
Experience in:
E xperience related to a Laboratory equipment qualification documents development, execution and report as well as laboratory test method creation and configuration in the applicable instrument...
...environmental programs, focusing on recognizing, evaluating, and controlling environmental hazards.
#Advices management on the proper... ...environmental sampling, reports monitoring results, and recommends control measures to management.
#Oversight the operation of the Waste...
...repair of the cooling tower.
~Monitoring and repair in humidity control system
~Operational monitoring of the automation system in a... ...of generators and fire pumps data taking.
~ Monitor / document effectively routinely operational parameters to ensure optimum...