Resultados de la búsqueda: 22 vacantes
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Job Description
The Senior Investigator Writer Leader is responsible for the writing and/or approval of quality events ( quality investigations, laboratory investigations...
...business processes, as well as the involved project management.
Job Description
The resource is responsible on managing process investigations, evaluates deviations with respect to their causes and corrective actions to prevent recurrence
Investigations.
Root...
...For Investigations s ervices in the Quality and Utilities area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor’s degree in Natural Science and at least five (5) years of exposure in Quality activities within the P harmaceutical Industry.
Bilingual (English...
...operations areas.
~ Ensures that deviation on documentation dealing with OOS or process parameters outside filing or validation are investigated and resolved by thoroughly reviewing timely corrective actions.
~ Provides key technical guidance and oversight to...
...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.
Coordinates projects to assure...
...preferably Microbiology with 2 years of experience in micro testing (ex. bioburden, endotoxins), and microbiology laboratory investigations.
Strong technical writing skills are required, as this resource will support the development and review of l aboratory investigations...
...6. Maintains statistics, develops reports and files official reports with regulatory agencies.
7. Administers the incident investigations program to determine rood cause and develop action plan to avoid recurrence and follows-up to ensure improvements are made.
8...
...batch records, forms, protocols, procedures, qualification, and validation reports. Enforce critical analytical thinking in the investigation management process specifically during root cause analysis, risk assessment evaluation and corrective and preventive actions determination...
..., presentations and reviews data to monitor product processing activities.
6. Leads and participates in out-of-trend product investigations with Senior Product Scientists and represents processing area as requested in fact finding meetings.
7. Leads process robustness...
...integrity, quality, adequacy, and appropriateness of validation documentation through comprehensive document review.
Ensure thorough investigation and timely resolution of issues related to equipment, facilities, and utilities.
Manage validation related, quality...
...Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
~Strong knowledge (according to related area).
~Technical Writing skills and investigations processes.
~Available to work extended hours, possibility of weekends and holidays....
...functionally and effective communication within the EHS Department while ensuring that information is timely, clear and accurate.
~ Investigate and prepare required reports of EHS system performance including but not limited to investigation reports, injury reports,...
...una red de contactos “networking”, y las siguientes destrezas; de persuasión, de prospectar, de hablar en público, de proceso de investigación, de negociación y cierre, de planificación, de identificación de necesidades del cliente, y de manejo de objeciones. Motivado y...
...Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
~Strong knowledge (according to related area).
~Technical Writing skills and investigations processes.
~Available to work extended hours, possibility of weekends and holidays....
...how they are applied to regulatory compliance.
~Strong knowledge (according to related area).
~Technical Writing skills and investigations processes.
~Available to work extended hours, possibility of weekends and holidays.
Responsibilities:
~OOS Lead Investigator...
...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.
#Coordinates projects to assure...
...product and computer systems validation protocols and reports, change control documentation, reprocessing / rework operations, investigation reports related to manufacturing process and analytical and microbiology laboratory.
Review/Approve equipment/facilities/system...
...The incumbent is responsible for the day-to-day decision making on technical matters related to troubleshooting, manufacturing investigations task items, CAPA’s, Change Controls, Stand Alone Actions.
• Takes immediate action and necessary decisions on manufacturing situations...
...agencies.
#Maintains statistics, develops reports and files official reports with regulatory agencies.
#Administers the incident investigations program to determine rood cause and develop action plan to avoid recurrence and follows-up to ensure improvements are made....
...how they are applied to regulatory compliance.
~Strong knowledge (according to related area).
~Technical Writing skills and investigations processes.
~Available to work extended hours, possibility of weekends and holidays.
Responsibilities:
~Creating long- and...
