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.