Manufacturing Operations Systems Support

Reference Number: ManOpsSystSup2021

Overview

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.
Work Level: Skilled
Job Type: Permanent
Salary: Market Related
EE Position: Yes