Quality Systems Expert
vor 3 Wochen
Description
About the role:
The Quality System Expert is responsible for supporting the Quality Systems group from an Administrator/Subject Matter Expert (SME) standpoint in accordance with Takeda policies, standards, procedures and Global cGMP.
The Quality Systems Expert insures that new or modified Quality Systems (Deviation, CAPA, Change control, Complaint, Risk managemenr, Documentation, LIMS, and QC systems, as assigned) are readily implemented and updated on site and insures that existing systems conform to internal and external quality standards.
They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business needs.
They are responsible for the first level support of end-users. They provides quality oversight and quality assurance (QA) support to partners (QA, manufacturing, projects). They actively participates to internal and external inspections.
How you will contribute :
Quality Management of Systems
Follow and implement changes in project/process or operational mode, depending on the perimeter and size of those changes
Assist end users with processes of systems and with resolution of issues, including coaching, training
Collaborate with our Business partners on site (Subject matter Expert) or on other Takeda sites to implement changes and improvements of systems
Proactively assist our business partners in expressing their needs in order to provide an adapted solution
Collaborate with Global teams and our peers from other Takeda sites
Process the users accounts requests for the different systems
Train superusers of systems and manage training toolkit associated
What you bring to Takeda:
Bachelor level degree in life technology fields (i.e. biotechnology, (bio)chemistry, engineering); advanced degree preferred
5+ years experience with at least 3 years with cGMP manufacturing and demonstrated administration of systems
Knowledge of a GMP environment
Knowledge and experience of Bio-Pharmaceutical
Knowledge and understanding of relevant regulations enabling effective partnerships across the organization
Multitasks, prioritizes and meets deadlines in timely manner
Ability to drive change
Demonstrated sound judgment. Must be confident, resourceful, self-reliant and self-motivated
Ability to work in a highly matrixed and geographically diverse business environment
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Ability to leverage and/or engage others to accomplish projects (project management)
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Strong organizational and follow-up skills, as well as attention to detail
French fluent and English level B2 or higher are needed.
Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process
Prepare oral and written communications and communicate problems to management with clarity and accuracy
Ensures appropriate deployment and coordination with global and within the site of the Quality Systems
Acts as Administrator/Subject Matter Expert for assigned Quality Systems and support the others and monitor quality system performance for emerging trends and search for improvement opportunities.
Participate to the audit team as appropriate and contribute to the audit preparation (pre requested documentation) the definition of the observation answer and follow CAPA plan implementation if applicable
As applicable, support preparation and the analysis of the indicators related to the compliance activity and propose improvement actions in case of indicators showing underperformance. Provide performance metrics to drive continuous improvement of the systems.
Deliver training which he/she is in charge
Participate to the deployment of the QMS simplification/integration
If applicable in charge of PQR definition for quality system he/she is SME
What Takeda offers you :
Competitive salaries
Full accident coverage
Participation in health insurance premiums
Advantageous pension plans
Subsidized meals
Financial participation in employee sports activities
Transport: support for local public transport passes, free parking, car sharing program
Takeda Neuchâtel offers its employees an attractive working environment and conditions. The well-being, safety, development and career advancement of its employees are at the heart of our vision and our Human Resources, Health, Environment and Safety policies
Takeda Neuchâtel is an employer committed to its employees and to future generations.
Learn more about Takeda Neuchâtel :
Locations CHE - Neuchatel
Worker Type Employee
Worker Sub-Type Regular
Time Type Full time
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