Manufacturing Operations Systems Support at Aspen Pharma Group

Responsible for the management, coordination and functional support of Manufacturing Operations Systems, and continuous improvement project roll-outs within the Manufacturing Operations Systems / Projects environment.

Responsibilities
Service Support

• Incident response and resolution through risk based problem solving while adhering to agreed SLAs.
• Problem Management to prevent incident recurrence and reduce impact of incidents that cannot be prevented.
• Request Fulfillment related to changes and support.
• 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 requirements are defined for Supplier Management.
• Ensure confidentiality, integrity and availability of data in line with regulatory requirements and company policies.

Service Transition

• Change Management, risk and impact evaluation.
• Management project stakeholders and report on Deliverables, Risks, Assumptions, Issues and Decisions.
• Service 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

• Build trusted Business Relationship with users to ensure business needs are met. 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/Engineering/IT business degree or diploma.
• Qualification in ITIL framework, agile methodologies, GAMP5 IT Systems Validation will be advantageous.
• 3-5 years pharmaceutical manufacturing
• 1-2 years process development / QA.

Specific Job Skills

• Good knowledge of Pharmaceutical GxP regulations.
• Advanced understanding of process and quality controls in Pharmaceutical Manufacturing
• Compiling / implementing / monitoring deviations, change controls, CAPAs, SOPs, validation protocols and reports.
• Proven Information Technology acumen and competency

Competencies

• Relational thinking.
• Dissemination of Technical Information.
• Improving Business Processes.
• Collaboration with Others.
• Emotional Intelligence.