Mbr Automation Specialist

3 months ago

Port Elizabeth, South Africa Aspen Pharma Group Full time

**Responsibilities**

**Service Operations**
- Request Fulfillment 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 - 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

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