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IT Quality Manager
PŘEDVÝBĚR.CZ s.r.o.
Místo práce
Praha, Jihomoravský kraj, Jihočeský kraj, Kraj Vysočina, Královéhradecký kraj, Liberecký kraj, Moravskoslezský kraj, Plzeňský kraj, Středočeský kraj
Praha, Jihomoravský kraj, Jihočeský kraj, Kraj Vysočina, Královéhradecký kraj, Liberecký kraj, Moravskoslezský kraj, Plzeňský kraj, Středočeský kraj
Druh pracovního poměru
plný úvazek
plný úvazek
Informace o pracovním místě
Náplň práce, pravomoci a zodpovědnosti
Lead and advise on quality activities (from initiation to completion on IT Projects) within the pharma / life sciences sector
• Creation and/or review and management of the designated validation deliverables such as System Risk Assessments, Validation/Qualification Plan and respective reports
• Apply the specifications of the customer’s Quality Systems and Standards to ensure that the quality of processes and deliverables of both projects and services meet their specified corporate and regulatory requirements
• Ensure computerized systems comply with all applicable GxP regulatory and customer’s requirements throughout the life cycle for the systems
• Liase with a wide range of Subject Matter Experts, including QA, Security, Data Privacy, Legal, and others to ensure high quality delivery
• Facilitate risk identification, assessment and mitigation planning for computerized systems
• Creation and/or review and management of the designated validation deliverables such as System Risk Assessments, Validation/Qualification Plan and respective reports
• Apply the specifications of the customer’s Quality Systems and Standards to ensure that the quality of processes and deliverables of both projects and services meet their specified corporate and regulatory requirements
• Ensure computerized systems comply with all applicable GxP regulatory and customer’s requirements throughout the life cycle for the systems
• Liase with a wide range of Subject Matter Experts, including QA, Security, Data Privacy, Legal, and others to ensure high quality delivery
• Facilitate risk identification, assessment and mitigation planning for computerized systems
Zaměstnanecké výhody, benefity
• Work on project in Prague
• You can start working immediately or during the summer
• You can start working immediately or during the summer
Informace o náboru
If you are interested in this offer, please sen dus your structured CV to e-mail address [email protected]. We will contact you as soon as possibe. Please, writte the name of the position in the e-mail subject.
Candidates, who are not suitable for the position will not be contacted by PŘEDVÝBĚR.CZ.
Candidates, who are not suitable for the position will not be contacted by PŘEDVÝBĚR.CZ.
Společnost, pro kterou je pozice obsazována
Informační technologie, počítačové programování, webové portály
For our client, a company that, provides Business Consulting, application development, security, collaboration and web application development, we are looking for suitable candidates on the position IT Quality Manager.
For our client, a company that, provides Business Consulting, application development, security, collaboration and web application development, we are looking for suitable candidates on the position IT Quality Manager.
Požadavky na zaměstnance
Pozici vyhovují uchazeči se vzděláním
vysokoškolské I. stupně
Jazykové znalosti
Anglický jazyk - Pokročilý (C1)
Osobnostní předpoklady a dovednosti
• University degree (Bachelor or Master) in Technical/Life Science, ideally enhanced by international work / study experience in an area relevant to Quality and Project Management
• Minimum of 5 years of experience in IT projects, Project Management, Quality Management including change management, risk assessments and risk management in the in the regulated Pharmaceutical Industry.
• Deep expertise in US FDA cGxP regulations, EU-GMP-Guide Annex 11 and US FDA 21 CFR Part 11 requirements & strong background with Quality Management and Computerized Systems Validation (CSV) aspects of application implementations and operations in the regulated Pharmaceutical Industry.
• Experience of Agile methodology for CSV and/or Software Development Lifecycle (SDLC)
• Able to work with a high degree of autonomy and self-management, being able to proactively find solutions to problems and knowing when to appropriately escalate issues
• Self-confident and assertive with excellent interpersonal and communication skills and the ability to demonstrate initiative and a flexible working style within a multi-national team
• Fluency in English (additional languages (e.g. German) advantageous) and the ability to communicate clearly and professionally, both verbally and in writing is essential
If you are interested in this offer, please sen dus your structured CV to e-mail address [email protected]. We will contact you as soon as possibe. Please, writte the name of the position in the e-mail subject.
Candidates, who are not suitable for the position will not be contacted by PŘEDVÝBĚR.CZ.
• Minimum of 5 years of experience in IT projects, Project Management, Quality Management including change management, risk assessments and risk management in the in the regulated Pharmaceutical Industry.
• Deep expertise in US FDA cGxP regulations, EU-GMP-Guide Annex 11 and US FDA 21 CFR Part 11 requirements & strong background with Quality Management and Computerized Systems Validation (CSV) aspects of application implementations and operations in the regulated Pharmaceutical Industry.
• Experience of Agile methodology for CSV and/or Software Development Lifecycle (SDLC)
• Able to work with a high degree of autonomy and self-management, being able to proactively find solutions to problems and knowing when to appropriately escalate issues
• Self-confident and assertive with excellent interpersonal and communication skills and the ability to demonstrate initiative and a flexible working style within a multi-national team
• Fluency in English (additional languages (e.g. German) advantageous) and the ability to communicate clearly and professionally, both verbally and in writing is essential
If you are interested in this offer, please sen dus your structured CV to e-mail address [email protected]. We will contact you as soon as possibe. Please, writte the name of the position in the e-mail subject.
Candidates, who are not suitable for the position will not be contacted by PŘEDVÝBĚR.CZ.
Inzerující společnost
Stručná charakteristika společnosti
Jsme ryze česká společnost, která již 10 let poskytuje personální služby.
Společnost je držitelem povolení ke zprostředkování práce.
Společnost je držitelem povolení ke zprostředkování práce.
ID: 3080748
Datum zveřejnění: 30.6.2017
2017-06-30
lokalita: Praha, Jihomoravský kraj, Jihočeský kraj, Kraj Vysočina, Královéhradecký kraj, Liberecký kraj, Moravskoslezský kraj, Plzeňský kraj, Středočeský kraj Pozice: IT manager, Manažer kvality Společnost: PŘEDVÝBĚR.CZ s.r.o.