Proclinical is currently recruiting for a CSV/Qualification Consultant for a pharmaceutical company located in Raleigh, NC.
- Act as Validation and Qualification Lead on a large laboratory remediation projects, with specific focus on Laboratory Standalone COTS systems.
- Author the typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.
- Assist systems users with defining, authoring and documenting system use in user, admin, and maintenance SOPs.
- Coordinate alignment of systems users from various company groups on validation and qualification documentation.
- Proactively communicate with various company organizations and systems vendors to ensure the project hurdles are overcome quickly and effectively.
- Provide tactical guidance and coaching in support of systems testing efforts with the stakeholders
- Act as validation task lead: take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc.
Skills and Requirements:
- 7+ years of Lab Systems CSV experienced is required, 10+ years are desired.
- Mettler LabX deployment, method development and validation experience (end to end) - pH, balance, titrators, refractometers, melting point and density meters; 2+ years' experience preferred.
- Specific hands-on experience with validating, qualifying, and/or using Pharmaceutical QC Lab Standalone COTS systems are required, including the authoring end to end of life cycle documents (including systems use and administration procedures).
- Understanding of Data Integrity concepts is required.
- Excellent communication and written skills required.
- Excellent communication and writing skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Max Kelly at (+1) 312-270-1613 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.