MBR Automation Specialist (Port Elizabeth) at Aspen Pharma Group

Description
Responsibilities

Service Operations

• Request Fulfillment related to e.g., new recipe creation, updates to existing recipes withing 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

Requirements
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