...uprawnienia na rynek USA poprzez weryfikację i egzekucję przepisów Federalnych Inspekcji Mięsa Departamentu Rolnictwa Stanów Zjedoczonych 9 CFR
sporzadzanie dokumentacji określonej w przepisach Federalnych Inspekcji Mięsa Departamentu Rolnictwa Stanów Zjednoczonych 9 CFR...
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Praca zmianowa
4 godziny dziennie
...response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-I.35(c)
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Knewin
Polska
1 dzień temu
...response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-I.35(c)
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Praca na pełen etat
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Telepraca
Umowa
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Elastyczny czas pracy
Knewin
Polska
1 dzień temu
...response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-I.35(c)
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Praca po godzinach
Knewin
Polska
1 dzień temu
...compliance role (Medical or other regulated areas)
A broad understanding of the Quality System regulations for medical devices (21 CFR, ISO 13485, MDR 2017/745, GMP, etc.).
Strong written and oral communication abilities required and ability to synthesize...
Zasugerowane
Praca na pół etatu
...managing projects funded by USG and deep knowledge of USG regulations, including relevant portions of -the Code of Federal Regulations (CFR) and related policies and procedures.
Excellent communication and relationship-building skills, with experience operating...
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Umowa
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Knewin
Polska
1 dzień temu
...Demonstrated successful setup and management of CROs and associated vendors, e.g., IRT, central laboratory, imaging.
•Thorough knowledge of CFR, ICH GCP, and GDPR/data privacy requirements.
•Self-starter comfortable working in a hybrid work environment with department and...
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Praca hybrydowa
Umowa
Praca zdalna
Elastyczny czas pracy
Nocna zmiana
Knewin
Polska
10 godzin temuNowa
...organization preferred.
Technical Skills and Abilities:
Thorough understanding of OMB compliance regulations, including 2 CFR 200.
Familiar with enterprise accounting software such as Jamis Prime, and the MS Office suite of applications, including SharePoint...
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Umowa
Praca zdalna
Elastyczny czas pracy
W godzinach popołudniowych
Knewin
Polska
2 dni temu
...Knowledge of Boeing aircraft structures.
Knowledge of finite element method approach.
Familiarity with FAA regulations (14 CFR Part 25 & 26).
At Boeing, we care deeply about the wellbeing of every employee. Some of the benefits open to you include:
Market...
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Praca na pełen etat
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Elastyczny czas pracy
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Boeing
Rzeszów
2 dni temu
...skomputeryzowanych m.in. protokołów i raportów walidacyjnych.
Przeprowadzanie walidacji systemów skomputeryzowanych zgodnie z wytycznymi GxP, FDA CFR 21 Part 11, GMP Annex 11, Aneksem 11 oraz 15 do rozporządzenia Ministra Zdrowia w sprawie wymagań Dobrej Praktyki Wytwarzania oraz...
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Praktyka/staż
Praca stała
Praca zdalna
Umowa
...response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
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Legalna praca
Viskase Companies Inc.
Polska
2 dni temu
...Quality Management System procedures and international standards and regulations, relevant for Medical Devices (like ISO 13485, FDA 21 CFR 820.30, MDR 2017/745, ISO 14971)
Analyzing state of the art for similar products and defining input requirements for projects, in...
Zasugerowane
Praca na pełen etat
Umowa
Telepraca
Praca zdalna
Elastyczny czas pracy
...response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-I.35(c)
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Zasugerowane
Praca zdalna
Umowa
Legalna praca
Knewin
Polska
1 dzień temu
...response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-I.35(c)
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Zasugerowane
Praca na pełen etat
Praca zdalna
Legalna praca
Umowa
Knewin
Polska
1 dzień temu
...response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-I.35(c)
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Zasugerowane
Praca na pełen etat
Praca zdalna
Umowa
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Knewin
Polska
1 dzień temu
...experience in supporting large, multisite, global organizations in life science industry with exposure to requirements of ISO 13485, CFR 820, GMP, GDP,MDSAP, MDR, GRC;
Familiar with important Financial & Medical Regulations and how they impact daily work (TüV, Validation...
Praktyka/staż
Elastyczny czas pracy
...regulations: SOC 1, SOC 2, SOC 3, ISO 27001, ISO 27017, ISO 27018, ISO 27701, FISMA, FedRAMP, SOX 404, HITRUST CSF, HIPAA, ISO 9001, GxP, 21 CFR Part 11, GAMP 5, EU Annex 11, NIST requirements
Ability to script in languages such as – python, shell, ruby, perl
Corporate IT...
...Minimum 2 years of experience in drug development and/or clinical research
Basic knowledge of ICH-GCP (R2), auditing, GDPR/HIPAA, CFR and other applicable (global/local) regulatory requirements
Process oriented
Analytical skills
Written and verbal...
Praca hybrydowa
Praca na pełen etat
Praca zdalna
Elastyczny czas pracy
2 razy w tygodniu
...związanych z oceną produktów oraz substancji aktywnych
Znajomość przepisów prawa Farmaceutycznego, Dobrej Praktyki Wytwarzania, 21 CFR 210/211.
Dobra znajomość MS Office.
Dobra znajomość j. angielskiego
Umiejętności komunikacyjne
Odpowiedzialność i...
Własną działalnością
Praktyka/staż
Praca stała
Umowa
Michael Page
Kraków
23 godziny temu
...Service Provider (FSP) and Full-Service Models, along with proficiency in navigating the clinical trial lifecycle and adhering to 21-CFR Part 11 regulations and validation processes
Experience with Phase 1 clinical environments
Well-versed in the utilization of common...
Umowa
Praca zdalna
...necessary coding),
Experience with laboratory equipment,
Experience in Unit / Integration level testing,
Understanding of FDA 21 CFR 820 and IEC 62304 software development standards are highly desired,
Knowledge in MISRA C (Nice to have),
Embedded C/C++...
Elastyczny czas pracy
LiNA Medical
Poznań
1 dzień temu
...systems (ISO 9001, GMP, ISO 13485) as well as documenting computerized system validation and regulatory requirements (GMQ Annex 11, CFR 21 Part 11, GAMP)
~ Experience and ownership of GxP system validation documentation and execution.
~ Understanding methodologies for...
Fresenius SE & Co. KGaA
Polska
4 dni temu
...laboratory track systems and instrumentation
• Generate and maintain proper complaint documentation in compliance with FDA (21 CFR) and ISO requirements.
• Coordinate with Quality Control, Quality Assurance, Research & Development, Marketing, Sales, Engineering...
Praktyka/staż
Praca na pełen etat
Praca zdalna
Umowa
Praca zmianowa
...Working knowledge of Azure, AWS or similar PaaS.
A strong knowledge of procedures and best practices related to FDA Regulations, 21 CFR Part 11, Computer System Validation, GAMP 5, GxP (GLP, GCP, GMP, and GVP) practices
Ability to communicate regulations and...
Praca na pełen etat
Praca zdalna
NOUS Latam
Polska
4 dni temu