CSV Consultant

Job location: Poland

Standard working hours: Monday- Friday
9.00 am – 5.00 pm

• Responsible for maintaining validated state of multiple, concurrent systems - Author, review, approve applicable CSV deliverables
• Support CSV activities in a risk based model, during project and operational phases of a system
• Provide support on inspection/audit readiness. Participate in mock audits and coordinate preparation for the same
• Authoring/contributing/reviewing system specific SOP/WI
• Handle end to end change control process
• Follow up/support deviation process and creation of Deviation Report/CAPA
• Make sure all project activities are carried out per the regulations, applicable SOP’s and policies

• At least 4 years of experience in CVS processes,
• Well versed with Pharma regulations – GAMP, GxP, 21 CFR part 1,
• Knowledge about Infrastructure qualification, system retirement activities, data migration,
• Excellent knowledge of Risk assessment – System and Functional,
• Fluent in English, Dutch: good to have but not must,
• Quick learner and adaptable to learn new processes, concepts, and skills,
• Strong attention to detail with a desire to deliver accurately, efficiently and to a high standard,
• Highly motivated with the ability to thrive in a fast-paced, high energy, and demanding team-oriented environment,
• Experience working in international environment is nice to have.

• Opportunity to be part of a rapidly expanding global organization with irreproachable reputation.
• Pleasant and inspiring working atmosphere.
• Professional development and clear career path.
• Training & development opportunities.
• Competitive salary with cafeteria benefits.