Master Batch Record(MBR) Automation Specialist at Aspen Pharma Group

Description

• Overview Performs product recipe functions (BOM, routing, master data management, master batch record creation, validation and change management) in MES and ERP. Coordinates and supports administrative functions within Quality Systems Department

Requirements

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 Accountability and Decision Rights
• Demonstrate initiative and apply advanced concepts.
• Exercise interpersonal, communication, training and problem-solving skills to optimize team performance.
• Resolve highly complex problems or out-of-policy issues. Independent decisions relating to:
• Technical risk based approach often in ambiguous situations, requiring advanced analytical skill, training / education.
• Establishing own work priorities and timelines.