...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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Zasugerowane
Praca na pełen etat
Praca zdalna
Telepraca
Legalna praca
Poranna zmiana
W godzinach popołudniowych
Knewin
Polska
4 godziny 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
Legalna praca
Elastyczny czas pracy
Knewin
Polska
1 dzień temu
...background OR; 6 months experience performing in a safety-related role within Amazon
Knowledge of OSHA regulations specifically 29 CFR 1910
Experience using Microsoft Word and Excel in a professional capacity
Experience maintaining confidentiality in matter...
Zasugerowane
Praca na pełen etat
Praca zmianowa
Elastyczny czas pracy
Nocna zmiana
...General Ledger & Systems:
Oversee all accounts, ledgers, and reporting systems ensuring compliance with appropriate US GAAP and CFR standards and regulatory requirements, experience with IFRS standards a plu.
Advanced knowledge of accounting and reporting software...
Zasugerowane
CORE Community Organized Relief Effort
Polska
2 dni 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
Legalna praca
Knewin
Polska
5 dni 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 60-1.35(c)
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Zasugerowane
Legalna praca
Viskase Companies Inc.
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
Legalna praca
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
...Knowledge of Boeing aircraft structures.
# Knowledge of the finite element method approach.
# Familiarity with FAA regulations (14 CFR Part 25 & 26).
# Experience in CAD/CAE systems (Catia, Nastran/Patran).
At Boeing, we care deeply about the well-being of...
Zasugerowane
Elastyczny czas pracy
Praca zmianowa
...GAMP 5 or other computerized system validation methodologies.
• Understanding of quality management systems based on ISO 13485 and 21 CFR Part 820.
• Understanding of relevant regulations / standards e.g., CFR 21 FDA Part 11, Annex 11, ISO 27001
• Project management...
Zasugerowane
Praca na pełen etat
Praca zdalna
Physiol
Polska
5 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...
Zasugerowane
Praktyka/staż
Praca stała
Praca zdalna
Umowa
...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...
Zasugerowane
Praktyka/staż
Elastyczny czas pracy
...kryteriów i wymogów jakościowych (ISO 9001)
Znajomość kryteriów i wymogów jakościowych (ISO 13485, ISO 14971, (UE) 2017/745 (MDR, 21 CFR part. 820,) – będzie dodatkowym atutem
Bardzo dobra znajomość MS Office (Word, Excel, PowerPoint)
Znajomość j. angielskiego na...
Zasugerowane
Praca stała
Praca hybrydowa
Praca zdalna
Elastyczny czas pracy
...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...
Zasugerowane
Fresenius SE & Co. KGaA
Polska
3 dni temu
...Pharmacovigilance Operations and PV affiliate Operations
Strong working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations, European Union (EU) Volume 10 clinical trials directive, Guideline on Good Pharmacovigilance Practices (GVP), and ICH...
Zasugerowane
Praca zdalna
...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...
...of quality management system principles (e.g. ISO 9001 or ISO 13485) and/or FDA quality system regulation processes according to 21 CFR part 820 and EU MDR.A team player with excellent interpersonal and communications skills, with the ability to solve problems ad-hoc.Experience...
Praca na pełen etat
Pale Blue Dot® Recruitment
Irlandia
1 dzień temu
...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
...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
W godzinach popołudniowych
Praca zmianowa
...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
...Quality Management System procedures and international standards and regulations, relevant for Medical Devices (like ISO 13485, FDA 21 CFR 820.30, MDD 93/42/EEC, MDR 2017/745, ISO 14971)
Analyzing state of the art for similar products and defining input requirements for...
Elastyczny czas pracy
LiNA Medical ApS
Poznań
4 godziny 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 60-1.35(c)
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Umowa
Legalna praca
Viskase Companies Inc.
Polska
1 dzień temu