Are you ready for your next challenge in QA and IT?
At MSD Haarlem we have an exciting opportunity for a:
Quality Specialist QA IT
As quality specialist QA IT you will be responsible for the quality aspects of GMP computerized systems and supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations. This includes involvement in quality-related activities for computerized systems which are required by the Quality Manual or with potential for impact on product quality, patient safety or data integrity. You will work closely with stakeholders and SMEs from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement.
Bachelors degree, preferably in Information Technology, Engineering, Laboratory, Quality or equivalent.
Hands-on experience in a regulated pharmaceutical manufacturing and/or laboratory environment (Quality or Compliance role in GMP or Medical Devices environment desired).
Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations.
Experience in delivering validated IT solutions or an application support role.
Good understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211 and 820 and local regulatory expectations.
Must demonstrate working knowledge of the principles, theories and concepts of computerized system validation / compliance.
Familiarity or practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment.
Limited supervision required in day-to-day activities.
Excellent oral and written communication skills in Dutch and English including persuading others and developing cross functional relationships .
Analytical problem solving skills, timely decision making, ability to respond to changing priorities.
Project management skills combined with a since of urgency and a proven history producing quality deliverables.