Qualification :
 Defines the risk-based qualification Plan for production / laboratory equipment, facilities, utilities and Computerized Systems (CSV)
 Performs the qualification of new, upgraded or existing assets incl. all required documentation within a given timeline and budget
 Writes and executes Impact Assessments, DQ’s, IQ’s, OQ’s as well CSV activities
 Supports creation of Change Control’s, URS’s, FMEA’s as well and PQ’s
 Participates in inspections as well as audits and drives investigations, deviations, corrective and preventive actions towards successful and compliant closure
 Assures compliance with all applicable cGMPs, regulatory requirements, safety, environmental regulations, SOPs, WI’s and Company policies
 Manage partnerships with contractors and vendors
 Bachelor’s Degree in Pharmacy
 Experience in the pharmaceutical industry + 8 years
 Experience in Sterile manufacturing is preferred
 Experience in a multinational pharmaceutical company is preferred.
 Very Good Command of the English language, word, Excel
 Communication and problem-solving skills
 Completed or exempted military service
 Awareness in Lean tools (5S, 7W, Poka Yoke, PDCA, JIT, Kaizen ……)

Interested candidates may send C.V.’s to: hr@gyptopharma.com