...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,...
...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....
...operations with Engineering Management and Operations Management.
Monitor and operate HVAC systems to ensure proper functioning and controlled environmental conditions for facilities rooms, including, Cooling Towers, Chillers, and other cooling systems to regulate...
...Provides technical and regulatory guidance on environmental programs, focusing on recognizing, evaluating, and controlling environmental hazards. To apply visit our site or send your resume to ******:Bachelor Degree in Science (Biology, Chemistry, Engineering or related...
...lot disposition recommendation when an investigation is completed as needed.
11. Manages audit observation, investigations, change control and CAPAs records in applicable QMS on timely manner.
12. Provides technical guidance and quality assurance support in the...
Somos un patrono con igualdad de oportunidades en el empleo que mantiene la política de emplear y retener a los mejores candidatos independientemente de la raza, color, edad, religión, sexo, origen nacional, discapacidad física o mental, orientación sexual, identidad de...
...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...
...technical aspects of test method ruggedness and robustness processes.
Supports the Analytical Ruggedness Project Manager and Quality Control to gather information on investigations, troubleshooting, method deviations, method optimization, and method change control....
...Parenteral Products.
GMP, FDA, EU regulations.
QA oversight manufacturing
Batch Record review and Protocol review
CAPA, Change Control and Annual Product Review
The Personality Part:
~ Being self-motivated means that you are curious, anxious to explore all...
...technical aspects of test method ruggedness and robustness processes.
#Supports the Analytical Ruggedness Project Manager and Quality Control to gather information on investigations, troubleshooting, method deviations, method optimization, and method change control....
...#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...
...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...
...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,...
...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...
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...
...and approves all equipment, utilities, facilities, process, product and computer systems validation protocols and reports, change control documentation, reprocessing / rework operations, investigation reports related to manufacturing process and analytical and microbiology...
...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 Good...
...the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipment, 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 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...
...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...
...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 /...
...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....
...for documentation, materials, training and equipment modifications.
~Supports establishment of process monitoring parameters and control limits.
~Supports the assessment of deviations and process monitoring data
~Monitors and evaluates parameters in existing (on-going...
...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...
...mejores prácticas establecidas para exceder las necesidades de nuestros clientes. Lidera y mantiene la motivación de los empleados. Controla el inventario y resuelve situaciones del día a día. Como Líder de ARKFICIO recibirás los siguientes beneficios• Bono de...
...Se solicita Vigilante de Seguridad para urbanización con acceso controlado. Entre las tareas se encuentra: Recopilación de información de visitantes, Rondas en facilidades recreativas, recibir a proveedores de servicios, entre otras. Puede enviar su resumé a ******:Debe...
...Chiller, primary and secondary pumps)
~Monitoring, operation and repair of the cooling tower.
~Monitoring and repair in humidity control system
~Operational monitoring of the automation system in a parenteral plant
~ Monitoring, operation and repair of air...
...Identify and evaluate equipment enhancements to support intended qualified operational ranges.
Support the evaluation of Change Controls to establish qualification assessments and performance qualification requirements during process and/or equipment modifications....
...the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipment , tools, or controls. The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and...
...drugs and packaging materials, Manufacturing Quality Assurance, Validation of product and processes, Quality Engineering, Quality Control, Training, Regulatory Compliance, Quality Planning, Product Quality and strategic initiatives. The Sr. Manager of Quality would be...