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 Wyróżnione Firmy |
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| Statystyki
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Osoby Online |
6
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Pracodawcy Online |
1
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Liczba ofert pracy |
3295
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Liczba Kandydatów |
3226 |
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GMP Compliance Manager
wolne wakaty (- -)
data publikacji (16-07-2010 09:26 am) |
Tytuł: |
GMP Compliance Manager |
Stanowisko: |
GMP Compliance Manager |
Kategoria: |
Inżynieria - Technologia
Technika - kontrola jakości
Top management
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Region: |
Unia Europejska - Holandia
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Firma: |
Balans Poland Sp. z o.o. |
Doświadczenie: |
od 10 do 15 lat |
Wykształcenie: |
Inne |
Umiejętności: |
Znajomość języków obcych
Organizacja własnej pracy
Zarządzanie Projektami
Pracy pod presją czasu
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Wynagrodzenie: |
- - |
Doświadczenie na stanowisku: |
Specjalista |
Rodzaj umowy: |
Stała - umowa o pracę
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Wymiar czasu pracy: |
Pełny etat
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| Opis Stanowiska |
" Provides QA support to GMP operations.
" Independently executes QA Operations in change control, document control, deviation resolution, CAPA, batch record review, and lot release.
" Issues and approves Certificates of Analysis and Certificates of Conformance.
" Reviews contract manufacturing organization (CMO) documents, SOPs, and batch records.
" Approves and closes deviations, document changes, CAPA's and change orders in compliance with SOPs and applicable regulatory requirements.
" Conducts root cause analysis and identify corrective/preventive actions, as appropriate.
" Plans, conducts and reports Quality Audits within GMP regulated areas both internally and externally.
" Reviews and revises current SOPs for QA operations as necessary.
" Evaluates and provides input into the development of Quality Systems.
" Provides GMP training to staff and contractors as needed.
" Establishes collaborative working relationships with other staff in Operations.
" Evaluates and directs the resolution of quality issues by developing effective interdepartmental and cross-functional partnerships.
" Identifies quality issues and communicate to manager as appropriate.
" Serves as the Quality representative on cross-functional and multi-site teams as required.
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