Overview
Experis is the global leader in professional resourcing and project-based workforce solutions. For our client a global pharmaceutical based in Neuchatel we arelooking for a QA Expert Junior
The primary responsibility of this role within the Quality organization is to perform activities related to the documentation process and system, including archiving activities, provide user support for documentation-related tasks, contribute to continuous improvement efforts and site initiatives, and ensure adherence to internal procedures and regulatory requirements.
Responsibilities
* System Ownership and user support
* Act as System/Process Owner or Administrator for the assigned process(es)/system(s).
* Maintain the Documentation Quality System, including proper archiving activities.
* Assist end users with processes or systems in area of responsibility and with resolution of issues.
* Train users and manage associated training toolkits.
* Process users accounts requests for the system(s) in area of responsibility.
* Create, update, approve and archive documents in area of responsibility.
* Perform relevant escalation/communication of critical issues.
* Participate in the continuous update of the team’s SharePoint.
* Continuous improvement and site initiatives
* Collaborate with our Business partners on site, other Takeda sites or Global to implement changes and improvements of systems.
* Proactively assist our business partners in expressing their needs to provide an adapted solution.
* Acts as Quality Representative in both routine and Takeda facility projects to support the quality system deployment and application to meet the current Regulatory Requirements.
* Support site initiatives and continuous improvement projects.
* Compliance
* Support for regulatory agency inspection and internal audits, closure of observations/audit items and regulatory submissions.
* Support the preparation of the local, Biologics Operating Unit and Global Quality Councils, if applicable.
* Support Gembas in GxP and non GxP areas
* Coordinate the collection of Quality Metrics/KPI on site, if applicable.
Provide back-up support for other Quality Systems, as assigned.
Critical / Key skills
* Degree in pharmaceutical sciences, life sciences, or a related scientific discipline.
* Minimum 2 years of experience in the (bio)pharmaceutical industry, ideally in a multinational company.
* Knowledge with GMP and regulatory guidelines (e.g., US-FDA, EMA, ICH).
* Good understanding of Good Data and Documentation Practices (GDDP) and Data Integrity principles.
* Knowledge of document version control, document workflows, and archiving.
* Awareness of audit and inspection readiness requirements.
Language & IT Skills
* Proficiency in using electronic document management systems (Veeva Vault).
* Proficiency in French and English (minimum B2 level or equivalent).
* Proficiency in Microsoft Office tools, including Word, Excel, Power Point and SharePoint.
* Strong communication skills (written and verbal) with ability to effectively communicate at multiple levels in the organization.
* Ability to work with cross-functional teams (e.g. other quality functions, manufacturing, supply chain).
* Ability to effectively manage multiple tasks, deadlines, and priorities in a fast-paced environment.
* Good analytical skills and ability to simplify the complex.
* Meticulous adherence to regulatory standards and quality policies.
* Ability to drive change and continuous improvement mindset.
* Ability to train end-users on systems and processes.
* Capability to troubleshoot quality-related issues and propose effective solutions.
* Ability to identify gaps or inconsistencies in quality systems or documentation compared to internal procedures and external regulations.
* Works with all other site functions and corresponding Global Quality Documentation representatives.
* Act as a back up of other Quality Systems team member as required.
Additional information
If you are interested in this opportunity, we look forward to receiving your CV or if you have any questions, contact Vladyslav Kadaiev on +41 58 307 2092. Due to Swiss work permit restrictions, we can only consider applications from EU citizens or holders of valid working permit in Switzerland.
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