Infrastructure qualification specialist

7 days ago

Chennai, India Mazo Solutions Full time
Job Summary: We are seeking an experienced Infrastructure Qualification Specialist with 10+ years of experience in qualification and validation processes for laboratory and manufacturing computerized systems in regulated environments. The ideal candidate will have a deep understanding of Gx P compliance , IT infrastructure qualification, and lifecycle management, with proven expertise in handling complex projects in the life sciences, pharmaceutical, or medical device industries. This role demands strong technical, organizational, and communication skills to ensure compliance and support IT infrastructure in a Gx P environment.
Key Responsibilities: Execute Computer System Validation (CSV) activities for laboratory and manufacturing computerized systems.
Design and develop qualification plans, including deliverables, user requirements, and functional specifications for Gx P-relevant infrastructure components.
Prepare test cases and scripts to verify qualification after changes to infrastructure components.
Create walkthrough narratives and process flow diagrams to identify key GMP controls and processing risks.
Execute qualification protocols, document deviations, and recommend resolutions.
Assess and qualify cloud infrastructure services supporting Gx P applications.
Coordinate and execute infrastructure component/platform test execution efforts.
Conduct Quality Control reviews of qualification activities and deliverables.
Maintain compliance with 21 CFR Part 11, EU Annex 11, and GAMP5 regulations.
Collaborate with system owners, technical representatives, and business owners to ensure compliance and quality.
Develop and implement continuous improvement strategies for qualification processes.
Provide objective evidence of qualification and proactively notify stakeholders of issues.
Perform other duties as assigned by management.
Qualifications: Experience:
10+ years of experience in qualification and validation writing and execution.
Strong expertise in IT compliance for life sciences/pharmaceutical/medical device industries.
4+ years of experience in Change Management processes related to IT infrastructure.
In-depth experience qualifying cloud services (Saa S, Paa S, Iaa S) and supporting Gx P applications.
Hands-on experience with SOC 2 reports, CUEC, and IT controls management.
Skills:
Comprehensive knowledge of qualification and validation processes in a Gx P environment.
Proficient in AWS Cloud services qualification, SAP ECC, and Open Text ALM.
Familiarity with Service Now Change Management processes.
Solid understanding of requirement specifications, system design, and testing methodologies.
Effective communication skills for engaging stakeholders across various teams.
Strong project management and organizational skills.

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