Job 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.

• 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.

• 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.

• Change Management, risk, and impact evaluation.
• Management project stakeholders and report on Deliverables, Risks, Assumptions, Issues and Decisions.
• MBR Validation and Testing xe2x80x93 Compiling requirements, risk assessments, specifications, and test protocols; testing and validation reporting.

• Build trusted Business Relationship with users to ensure business needs are met.
• Understand and anticipate customer demand through demand management processes.

• Regularly review services to improve quality and identify areas where processes can be improved.
• Implement and monitor CSI initiatives.

• 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.

• 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.

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