Please refer to JobSuchmaschine in your application
CSV LEAD (F/M)
Edelweiss HR is specialized on the placement of high-quality candidates, permanent staffing solutions for companies with HQ in Europe. On behalf of our client, an international life science company, we are looking for a motivated personality as:
CSV LEAD (F/M)
As a Computer System Validation (CSV) Lead you will provide quality and compliance support for manufacturing, laboratory, and business systems with an emphasis on CSV. Main focus is on the development and generation of validation strategies and deliverables for sites in DNP OPS-EU/CN region and Global Quality IT systems.
• Develop and manage a harmonized, global CSV methodology that sites across the business unit will use to validate their computer systems.
• Responsible to interface with various sites in EU/CN region and support their various CSV needs and projects.
• Provide subject matter expertise and support to Global Quality IT systems and projects.
• Train and develop a CSV knowledgeable workforce across the sites who can develop validation deliverables.
• Support various sites during customer, regulatory, and certification audits on matters of CSV.
• Develop reporting mechanisms to keep track of various CSV efforts across EU/CN region.
• The CSV lead, as needed, should be capable of creating various SOPs, Policies, templates, assessments, plans, requirement specifications, test protocols, reports etc.
• Follow all company Life Saving Rules.
• Show leadership by working to SHEQ standards and encouraging fellow employees to work to the same standards
• Bachelor’s Degree in Engineering or related Life Science is required
• Minimum 5 years of validation experience in a FDA regulated life science industry (i.e. – Biotech, Pharmaceutical) is required
• Experience validating and working with various types of lab, manufacturing, and business systems is ideal
• Experience with Quality Systems and regulations (i.e.-ISO, FDA and cGMP) is a must
• Experience in Technical writing and drafting various CSV deliverables (Plans, Specifications, Test protocols, Requirements Trace Matrices, Reports etc.)
• Proficiency in MS Office Applications and experience using various applications such as – SharePoint, EDM/Documentum, TrackWise, SAP, LIMS etc. would be ideal
• Fluent in English; excellent oral and written communication skills
If you want to become part of a very team-oriented and dynamic organization where your contribution will be recognized and rewarded, please apply online.