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