Not specified, but likely hybrid based on the nature of the role and industry.
5+ years compliance activities experience
21cfr part 11 regulatory knowledge
Emea annex 11 compliance expertise
MSD International GmbH is seeking a Senior Specialist for IT/OT Compliance in Singapore, responsible for managing regulatory compliance programs and engaging with internal and external auditors. The ideal candidate will have extensive knowledge of compliance activities in a GxP environment and strong communication skills to collaborate with various stakeholders
Job Summary
The role involves administering regulatory compliance programs with a focus on risk-based and lean approaches for IT and OT systems.
Candidates must demonstrate the ability to manage internal and external auditors while executing risk assessments for new technologies.
This position requires championing changes to SDLC policies and reporting on deviations and CAPAs to ensure conformance to quality records.
Matching Summary
Match Score: 85
MSD International GmbH is seeking a Senior Specialist for IT/OT Compliance in Singapore, responsible for managing regulatory compliance programs and engaging with internal and external auditors. The ideal candidate will have extensive knowledge of compliance activities in a GxP environment and strong communication skills to collaborate with various stakeholders.
Skills & Requirements
Must-have
5+ years compliance activities experience
21CFR Part 11 regulatory knowledge
EMEA Annex 11 compliance expertise
ISAS95 and S88 standards application
Cloud and SaaS validation skills
Internal and external auditor management
Nice-to-have
Post Graduate in Business Strategy
Manufacturing analytics systems experience
Real-time shopfloor system integration
Biologics process modelling background
Cross industry collaboration experience
Business process re-engineering principles
Key Requirements
Bachelor's Degree in Computer Science, Engineering, or Regulatory Compliance
Minimum 5 years supporting compliance activities
Proficiency in computerized systems validation regulations
Working knowledge of GxP environment standards
Experience in pharmaceutical manufacturing or supply chain