CSV Expert

QC Analytical Instrument, Lab. Computerized System Validation Specialist

Experis is the global leader in professional resourcing and project-based workforce solutions.

On beahlf of our Pharmaceutical company in Neuchatel we are looking for a CSV Expert with experience in QC Analytical Instrumen and Lab. Computerized System Validation.

Start Date: ASAP/October 14th 2024
Contract Duration: 12 months (extension is possible)
Location: Neuchatel

Duties:

• The job holder is accountable for life cycle management activities of systems used in the QC Laboratories of Neuchâtel - Switzerland with a focus on:

- Analytical Instrument Qualification
- Computerized System Validation
- In addition, the job holder also supports the Data Integrity deployment in the department following cGMP, policies and EHS requirements.

Validation and Qualification Activities:

• Author specification documents (URS-FS-SDCS).
• Author plans, protocols, and reports
• Execute and documents Equipment & Software validation.
• Oversee validation and qualification activities executed by analysts, provide training and support.
• Assure cGMP compliant and timely implementation and maintenance of validated status of systems.
• Conduct/participate in risk assessments, root cause analysis and investigations.
• Identify, lead and drive improvements or change.
• Provide technical assessments on protocols deviations and investigations.
• Serve as SME for internal technical group discussions.

Quality Control Support Activities:

• Support and interface with process owners of systems.
• Participate to daily activities upon request (provide technical and statistical support)

Experience:

• Master's in engineering, Computer Science, or related technical field
• Minimum of 5 years of relevant validation experience in the biotechnology or pharmaceutical industry
• Extensive experience with validation life cycle requirements for cGMPs laboratory systems
• Experience with project management and/or leadership enabling cross functional engagement to deliver project goals and timelines.
• A thorough knowledge of DI requirements and standard regulations for cGMPs operations
• Provides input on project execution and acts as a consultant to management.
• Authors and reviews protocol and reports as per established company guidelines and SOPs.
• Identifying and communicating risks in area of responsibility and across the site.

Language & IT Skills:

• Fluent in French and English (C1 written and spoken)
• Proficiency in all aspects of standard IT tools

Key Skills, Abilities, and Competencies:

• Strong project management skills to support project delivery and operational readiness
• A proven ability to lead cross functional teams and deliver on tight timelines
• Demonstrate flexible and innovative approach to work
• Excellent collaboration skills and teamwork mindset
• Excellent trouble shooting and problem-solving skills as well as an ability to coach and mentor self-directed teams through complex problems solving
• Ability to challenge the status quo with a continuous improvement mindset
• Ability to work independently in a fast-paced environment
• Ability to manage multiple priorities and know when to escalate issues for resolution
• Effective communicator and strong decision maker
• Demonstrated ability to synthesize information and defend conclusions publicly
• Demonstrated ability to give and receive feedback

If this job interests you please do send us your CV today through the link in the advert. However, should you have any questions please contact Elaine Kanwar elaine.kanwar(at)experis.ch or at +41 61 282 22 23