IT Compliance - Business Analyst / Advanced Business Analyst - India
- IT Shared Services (ITSS) team in our company is a unit of the Corporate IT India comprising of talented IT specialists colleagues and growing fast.
- CORPORATE IT India is an integral part of IT, Quality & Corporate Development in Denmark which currently consists of approximately 300+ highly skilled IT professionals worldwide responsible for all major IT projects and IT systems in our company.
- ITSS offers services to provide compliance/validation activities to the internal line of businesses within company globally.
- ITSS works closely with System managers, ITQCs, subject matter experts and colleagues in the other areas of IT Shared Services/other departments in Denmark as well as with the company IT organisation in India.
- Perform compliance related tasks provided as services from the department
- Develop plans, execute and deliver the services with acceptable service evaluations.
- Perform stakeholder management as a part of delivering services involving multiple stakeholders.
- Able to perform CAPA and RCA using 5 x Why approach or any similar approach
- Able to take up IT Quality co-ordinator and Validation Responsible roles at various stages of IT project.
- Should be able to provide compliance consulting for the IT projects at every stage of a V-Model development
- Collaborate with stakeholders/partners with diverse interests, knowledge, cultural background and personality.
- Excellence in CSV understanding
- Awareness in ITIL concepts including Incident/Problem and Change Management
- Efficiently author / review yearly reports with respect to User Setup and Configuration Management
- Efficiently author / review Validation Status Summary Reports
- Handle Nonconformities and/or Remarks for IT Systems
- Internal audit support and facilitating the closure of the identified Audit NCs
- Test coordination / validation for system corrections / system releases
- Demonstrate resourcefulness and ownership
- Manage time planning for tasks Communicate and involve relevant stakeholders
Qualifications (minimum requirements):
- M.Sc., B.Sc. or similar graduate degree in relevant field (Computer Science or equivalent)
- Excellent communication skills in English and comfortable working with different cultures
- Min 5+ years of experience in working in the IT quality domain.
- Min 4+ years in performing RCAs, CAPA and any other relevant IT compliance/validation activities.
- Min 2+ years of practical experience in GxP areas with exposure to regulatory affairs.
- Min 2+ years of experience in validation activities of a IT Project in a pharma domain
Leadership competencies expected:
- Live the company values and be a role model to employees
- Quality Mind-set and should be able to advice/challenge decisions in the interest of quality
- Keep an up to date knowledge on IT service management through various industry framework
- Foster innovation and continuous improvement in the department
- Inspire and motivate employees
- Collaborate across boundaries