Issa Business Quality Manager
AstraZeneca / Kemiingenjörsjobb / Göteborg
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hela Sverige AstraZeneca is looking to recruit a Business Quality Manager to join the Information Strategy, Systems and Analytics (ISSA) function. The position can be placed either in Gothenburg (Sweden) or Macclesfield (UK).
Information Strategy, Systems and Analytics (ISSA), as part of Delivery and Enablement (D&E), is accountable for the effective governance, maintenance and enhancement of GRAPSQA (Global Regulatory Affairs, Patient Safety and Quality Assurance) systems owned by ISSA, and for delivering expert services in support of their use by the business. ISSA ensure that the company's pharmacovigilance, regulatory and legal obligations, in respect of these systems, can be fully met.
Reporting to the ISSA Section Director, with primary accountability for system compliance the ISSA Business Quality Manager is responsible for ensuring that the systems which ISSA own are fully compliant with the GxP and other requirements arising from the regulated business processes which they underpin.
As a Business Quality Manager in GRASPQA, you work in an open and collaborative environment of scientists, directors and physicians covering both regulatory affairs and patient safety, with focus on global submissions and license to operate.
Main Duties and Responsibilities
* Responsible for ensuring that GxP regulatory compliance requirements on ISSA-owned computerised systems that support GxP regulated business processes are understood and met.
* Responsible for Quality Management oversight of computerised systems owned by ISSA, ensuring all regulatory requirements are considered, and that the necessary validation documents exist, and that they are clear, complete and retrievable.
* Maintains an overview of the ISSA system estate, from a QM perspective, as well as a rolling 'high-level' view of system change, facilitating easy access to the system compliance status.
* Approval of the Regulatory Impact Determination (RID) for all ISSA-owned systems, and provision of expertise into the generation of the RID, to determine whether or not a system has potential GxP impact and needs to be validated. Participation in Privacy Impact Assessment and eDiscovery assessment as part of the RID.
* Review and approval of User Requirements Specification for all ISSA-owned systems, ensuring that any requirements which relate to GxP, or which could impact patient safety, product quality, or records required to be created and maintained in support of GxP, are included and clearly identified as GxP within the URS.
* Responsible for providing input to the high-level risk assessment process to ensure that risks relating to GxP impact are included and managed.
* Review and approval of the Validation Plan for all ISSA-owned systems, ensuring the activities planned are appropriate to address the GxP requirements, including the approach for User Acceptance testing.
* Responsible for signing off all ISSA-owned systems into use via approval of User Acceptance Testing and the Validation Report, which must provide sufficient evidence to support the compliance status of the system.
* Participates in project audits, quality management reviews and inspections as necessary, providing an independent 'quality' voice, as well as functional and business quality expertise.
* Maintains a robust and 'up to date' knowledge of all internal and external regulations pertaining to computer system validation, with particular emphasis on GxP processes, providing appropriate recommendations for change as necessary.
Requirements
* Bachelor's degree or equivalent experience within the pharmaceutical or IT industries.
* Experience of computer system validation in a regulated environment, preferably the pharmaceutical industry, including familiarity with documentation such as Validation Plans, Reports, Test scripts etc.
* Demonstrated knowledge of and experience from working with regulatory (GxP, GDPR, SOX etc.) requirements for computerised systems and infrastructure.
* Ability to proactively identify potential compliance issues and subsequently advise on their avoidance/resolution/remediation, by formulating an independent and objective recommendation.
* Maintain an interest in and knowledge of current developments in the pharmaceutical industry and its global regulatory environment, and its potential impact on regulatory compliance, pharmacovigilance, signal and risk management activities, safety value demonstration and safety science-related activities.
* Good understanding of current best praxis for system development lifecycle methodologies.
* Strong decision making and influencing skills.
* Understanding of and management of risks.
* Innovative thinking, with enthusiasm, energy and drive.
If you are interested, apply now!
Welcome with your application no later than October 29th, 2018.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2018-09-26ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2018-10-15
Ange följande referens när du ansöker: R-036384
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
jessica.tangefjord@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparredsleden 1
Jobbnummer 4368024
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