Master Batch Record Automation Team Leader (Port Elizabeth) at Aspen Pharma Group

Description

Responsible for the management, coordination, and operational support of Manufacturing Operations. Systems, and continuous improvement project rollouts and new product launches within the Manufacturing Operations Systems / Projects environment.

Requirements

Leading Service Operations

• Provide technical and operational input on operational planning of the MBR design team and on the prioritization of objectives.
• Provide input into budget and resource requirements of section.
• Request, allocate and monitor use of assets and resources.
• Provide section staff with day-to-day direction and tasks.
• Run effective performance review meetings.
• Ensure visual performance boards are updated.
• Complete and monitor time and attendance.

Service Design

• Manage service definitions and team capacity.
• Compliance of IT services, processes and systems with company policies and regulatory requirements.
• Alignment to architecture strategy, policies, and standards.

Service Transition

• Change Management, risk, and impact evaluation.
• Management project stakeholders and report on Deliverables, Risks, Assumptions, Issues and Decisions.
• MBR Validation and Testing – Compiling requirements, risk assessments, specifications, and test protocols; testing and validation reporting.

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.

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.
• 1 year supervisory / managerial experience.

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

• Proven leadership abilities.
• Relational thinking.
• Dissemination of Technical Information.
• Improving Business Processes