Merck KGaA

IT Compliance Expert

Posted On

Dec. 23, 2024

Location

Bangalore, Karnataka

Experience Level

D - Professional (4-9 years)

Job Type

Full-time

Apply By

Jan. 14, 2025

Job Description

An excellent opportunity has become available for a dynamic IT Compliance Manager (Expert role, no people management) responsible for supporting governance and compliance frameworks in Enabling Function IT. This position interacts with Corporate and Functional Quality personnel as well as Infrastructure and Application areas of IT. The candidate will be responsible for the support of established frameworks for System Qualification and will act as Validation Owner specifically for our IT Service Management tool (based on Service Now platform). You will provide training, consultation, guidance and mentoring to IT personnel responsible for qualification activities. This position is also responsible for providing day-to-day support and consultation for regulated change activities, including as VO for IT Service Management tool. A key part of this position is the ability to work independently and with cross-functional and cross-cultural teams to collaboratively support qualification and change activities. The position is based in Bangalore, India and works the evening shift (13:30 - 22:30 IST). Who you are:• You have a Bachelor degree in Business Administration or Information Technology (relevant professional experience may be taken into consideration).• You have a minimum of 5 years’ experience in IT support roles, including 3 years as Validation Owner or Validation Manager with demonstrated expertise in Computerized System Validation lifecycle and requirements.• You are a team player with senior expertise combined with good knowledge of the market and competitors, you have peer networks and keep up to date with trends and best practices• You have detailed knowledge of GAMP5 and relevant GxP requirements including Data Integrity, 21 CFR Part 11(ERES), EU Annex 11, and ICH guidelines• You have experience in conducting risk assessments, impact assessments, managing deviations, and authoring high-level validation documents such as the Validation Plan and Validation Report.• You have good understanding of and demonstrated experience with Electronic Quality Systems (Change Control, Document Management, HPALM, etc.) along with technical understanding of IT infrastructure and cloud based services• You have proven understanding of Good Documentation Practices and a strong quality mindset and understanding of quality oversight.• You have native-level English proficiency and excellent presentation & communication skills.• You are a creative and independent thinker, able to balance priorities, support pragmatic but compliant proposals, and self-organize to meet timelines.

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