Responsibilities Service Operations Request Fulfillment related to e.g., new recipe creation, updates to existing recipes within agreed SLAs Incident and problem management related to MBR design Co-ordination of technical resources to ensure adherence to agreed Service request SLAs Application Management throughout entire system lifecycle Service Design Design and coordination with key business stakeholders Compliance of IT services, processes and systems with company policies and regulatory requirements Alignment to architecture strategy, policies, and standards Ensure confidentiality, integrity, and availability of data in line with regulatory requirements and company policies. Service Transition Change management, risk and impact evaluation Manage and execute project activities, stakeholders and report on Deliverables, Risks, Assumptions, Issues and Decisions. Batch Record Validation and Testing – Compiling requirements, risk assessments, specifications, and test protocols; testing and validation reporting Service Release as per Service Introduction procedures Asset and Configuration Management. Update Knowledge Base to improve efficiency. Service Strategy Understand and anticipate customer demand through demand management processes Continuous Service Improvement Regularly review services to improve quality and identify areas where processes can be improved Implement and monitor CSI Initiatives Skills Required Background/Experience
Pharmaceutical (B Pharm) / Engineering / IT Business Degree or diploma 1-3 years pharmaceutical manufacturing experience or Control & Automation, relevant IT development experience Extensive experience working within a Pharma Quality Management System (QMS) with automated workflows Specific Job Skills Good knowledge of local registrations and regulations and of international regulations/guidelines concerning GDP/GMP Advanced understanding of the pharmaceutical manufacturing processes Pharmaceutical standards and compliance requirements Excellent computer/IT system skills and competencies Information Gathering and Interrogating information Offering Insights Endorsing Quality Standards
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