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IT Validation and Compliance Expert
1 month ago
We are a global healthcare leader that delivers innovative medicines to patients worldwide.
Job DescriptionAs an IT Validation & Compliance Specialist I, you will be responsible for performing activities related to Computer System Validation (CSV) / Computer Software Assurance (CSA) in line with our Quality Management System (QMS). Your duties will include validation for GxP Computerized Systems/ Computerized Equipment both in project and operations phase. You will also participate in audits and inspections, including finding solutions to compliance gaps identified in audit/inspections.
Your responsibilities will also include managing yearly periodic review reports, upkeeping audit readiness checklist and all system level documentation (e.g., risk assessments, plans, reports, requirements, and specifications) up-to-date. Additionally, you will be responsible for preparing the Release plan for releases and driving all the release-related activities.
Key Responsibilities- Performing CSV/CSA activities in line with QMS.
- Participating in audits and inspections, including finding solutions to compliance gaps.
- Managing periodic review reports and audit readiness checklist.
- Preparing Release plan for releases and driving release-related activities.
To be successful in this role, you should have:
- Bachelor's or Master's degree in relevant field with minimum 8-10+ years of experience in IT or equivalent industry and minimum 4+ years of GxP Validation& CSV /Testing experience working with pharmaceutical requirements.
- Experience in Risk assessment (IT Risk Assessment related to: Business Process, Solution, Data Integrity, IT Security, Functional, Supplier) and exposure to Test management tools such as HP ALM.
- Experience with supplier assessment, deviation handling, change management, and good understanding of GAMP 5 and various Regulatory requirements including CFR part 11, EU Annex 11.
- Expert in performing validation activities for complex projects and ability to represent NN in relations with users and external stakeholders.
- Good to have experience in Agile methodology & waterfall methodology, usage of Azure DevOps (ADO) etc.
- Experience in drafting test cases & reviewing test cases and approving test cases in Leapwork (Good to have) or any other automated test management tool.
- Good to have Industry recognized ITIL and Scaled Agile Framework (SAFe) 5 Practitioner.
- Excellent interpersonal and communication skills including verbal and written communication. Ability to represent NN in relation with users and external stakeholders.
- Minimum 5+ years in performing RCAs, CAPA and any other relevant IT quality assurance activities.
This position is anchored within DD&IT Development unit in DD&IT GBS India in the department Site Collaboration Solutions. The team which is basically composed in an ART set up also ensures interactions with clinical sites, investigators, and clinical staff with regards to different IT support as well as development.
The salary for this position is estimated to be around $120,000 - $150,000 per year, depending on your experience and qualifications.