Job Description

• 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.

Service Operations

• Request Fulfilment 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 xe2x80x93 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.

Aspen Pharmacare