Senior IT Compliance Officer
4 days ago
Our goal is to ensure operational readiness for mission-critical industries.
As a Quality Control IT Specialist, you will be responsible for developing and maintaining clear procedures for data handling, system validation, and IT processes.
- Strong oral and written communication skills with focus on clear documentation and reporting.
- Excellent problem-solving skills with a quality control mindset.
- Strong customer-service orientation.
This role supports quality control by ensuring compliance with data integrity and IT standards throughout all documentation and equipment qualification activities.
The successful candidate will be responsible for reviewing and verifying Test Outlines and Procedures (TOPs) for IT systems, coordinating IT system qualification activities, preparing and maintaining Qualification Summary Reports (QSRs) and other documentation to track compliance with quality and DI standards, conducting reviews of system Design Evaluations, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to verify quality outcomes for IT systems, managing QC processes related to IT qualifications including document control, change controls, and oversight of DI compliance, collaborating with IT project teams, contractors, and vendors to execute and validate testing, allocating resources and supporting the organization of documentation and materials needed to meet QC and IT deliverables, providing quality assurance support throughout IT system qualification ensuring that all documentation meets regulatory and DI requirements.
The ideal candidate should possess a Bachelor's or Master's degree in a relevant science or engineering field or equivalent experience. A minimum of 3 years of industry-related experience is also required.
We seek an individual who is proficient in life science manufacturing processes such as biotech, aseptic fill/finish, oral solid dose (OSD), and gene therapy or equivalent experience.
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