For two of our clients of the pharmaceutical industry based in the Neuchatel area, we are currently seeking Quality Assurance Specialists for an initial short term mission.
Main responsibility: Ensure effective management of documentation processes and systems within the Quality organization, including archiving, user support, compliance, and continuous improvement.
Responsibilities
System Ownership & User Support
* Serve as System/Process Owner or Administrator for assigned systems/processes.
* Maintain the Documentation Quality System, including proper archiving activities.
* Provide user support for documentation-related tasks and issue resolution.
* Train users and manage training toolkits related to documentation systems.
* Process user account requests for relevant systems.
* Create, update, approve, and archive documents within scope of responsibility.
* Escalate and communicate critical issues as needed.
* Contribute to the continuous update and maintenance of the team's SharePoint site.
Continuous Improvement & Site Initiatives
* Collaborate with local and global business partners to implement system improvements.
* Support business partners in identifying needs and proposing adapted solutions.
* Act as Quality Representative in routine operations and facility projects.
* Participate in site initiatives and continuous improvement efforts.
Compliance
* Support regulatory inspections, internal audits, and closure of observations.
* Assist in preparation for local, Biologics Operating Unit, and Global Quality Councils.
* Participate in Gemba walks in GxP and non-GxP areas.
* Coordinate collection and reporting of site Quality Metrics/KPIs.
Cross-Functional Support
* Provide backup support for other Quality Systems as assigned.
* Collaborate with other site functions and Global Quality Documentation representatives.
Qualifications
Education & Experience
* Degree in pharmaceutical sciences, life sciences, or related discipline.
* Minimum 2 years of experience in the (bio)pharmaceutical industry, preferably in a multinational environment.
Regulatory & Quality Knowledge
* Familiarity with GMP and regulatory guidelines (e.g., US-FDA, EMA, ICH).
* Understanding of Good Data and Documentation Practices (GDDP) and Data Integrity.
* Experience with document version control, workflows, and archiving.
* Awareness of audit and inspection readiness requirements.
Language & IT Skills
* Proficiency in electronic document management systems (e.g., Veeva Vault).
* Fluent in French and English.
* Skilled in Microsoft Office tools: Word, Excel, PowerPoint, SharePoint.
Soft Skills & Competencies
* Strong written and verbal communication skills across organizational levels.
* Ability to work effectively in cross-functional teams.
* Skilled in managing multiple tasks and priorities in a fast-paced environment.
* Analytical mindset with ability to simplify complex topics.
* Detail-oriented with strong adherence to regulatory standards.
* Change agent with a continuous improvement mindset.
* Capable of training users and troubleshooting system/process issues.
* Able to identify and resolve gaps in documentation and quality systems.
What We Offer
* Continuous support during the mission
* Well renowned client
* Good infrastructure