Quality Systems Expert
vor 6 Monaten
**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**:
- With more than twenty nationalities, Takeda Neuchâtel offers an international, _diverse_ and innovative wor
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