Job Opportunities at Aspen Pharma Group

Overview

Performs product recipe functions (BOM, routing, master data management, master batch record creation, validation and change management) in MES. Coordinates and supports administrative functions within QS.

Responsibilities

• QS coordination and support
• Provide QA IT systems support
• Ensure manufacturing processes, duties and activities are designed according to GMP and regulatory requirements
• Perform process evaluation, including reporting of process and system deficiencies and following up on corrective actions
• Master data management
• Define and manage critical data relating to quality
• Ensure adherence to product master data standards
• Master batch record (MBR) creation and validation
• Create new item IDs on the ERP
• Create and maintain precise, detailed and compliant manufacturing instruction/ description documentation on the system
• Check that MBRs contain all pharmaceutically relevant data, including input material list, valid SOPs, detailed work instructions, process data/ steps (e.g. IPCs, CPPs, CQAs)
• Ensure that MBRs are GMP compliant
• Ensure proper MBR change controls in process compliance

Procedure and document compliance

• Align engineering and QA policies and configure system for cleaning and hold times, maintenance, calibration, and equipment tares
• Implement quality manuals and policies
• Conceptualise, initiate and author SOPs and process documents Identify, process and store records and review output documents
• Conduct reviews of protocols for product launches

Audits and reporting

• Conduct root cause analysis and risk assessments and report
• Participate in QMS monthly and annual reviews
• Conduct and report on statutory external (regulatory) audits

Planning and operational support

• Provide technical and operational input during drafting of quality plans and procedures specific to unit
• Request, allocate and monitor the use of MES related assets and resources for the fulfilment of work objectives
• Stay up to date on developments, trends, legislation and regulations
• Provide information for reports, as required by superior

Job Requirements

• Background/experience
• Bachelor’s degree (B Pharm) with 4-6 years’ related work experience
• Pharmaceutical manufacturing experience
• Extensive experience working with compliance procedures and administrative process automation

Specific Job Skills

• Good knowledge of local registrations and regulations and of international regulations/guidelines concerning GDP/GMP, QA
• Advanced understanding of the pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Excellent computer/ IT system administration skills

Competencies

• Information Gathering
• Interrogating Information
• Offering Insights
• Endorsing Quality Standards

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Overview

To ensure all Manufacturing Execution Systems Infrastructure is architected, maintained, documented and controlled on a daily basis. To develop control systems that aligns to disaster recovery processes.

Responsibilities

Operational Activities

• Ensure efficient service delivery to customers and suppliers internally and externally.
• Ensure Hardware and Software support resolved as per request
• Feedback regarding outputs on a regular basis, and methods for improving customer services are proposed, developed and continuously updated.
• Ensure that the security and licenses are managed as per department requirements, that technology is utilised competently as per qualification requirements and that training is acquired to accommodate new technology.
• Ensure adequate capacity planning and monitoring to ensure that business requirements are met.
• Ensure that the computer hardware architecture is designed to meet business requirements
• Ensure Problem Management discipline is implemented and followed.
• Ensure proactive monitoring is in place.
• Ensure the availability of standard operating procedures for processes, and utilise accordingly.
• Ensure that information is confidentially maintained and securely stored and that documents and reports are completed in an accurate and disciplined manner.
• Ensure the effective implementation of technology standards in the MES environment
• Identify and contract various component parts necessary to deliver the services through Operating Level Agreements

Human Resources

• Promote diversity, equal opportunity and fair treatment in the workplace GMP
• Complete all records and reports timeously and accurately as described in the relevant SOP’s, protocols and associated documentation.
• Comply with GMP/GLP requirements as outlined by company SOP’s and written instructions in all tasks and activities
• Ensure that products are produced, tested and stored according to the required SOP’s and documentation

Health, Safety and Environmental Standards

• Carry out any duty or requirement imposed on the company by the OHS Act and in accordance with your specific SHE appointment
• Report any unsafe or unhealthy situations to SHE representative or Line Manager
• Report any incident to the SHE representative or Line Manager which may affect your health or cause injury

Background/experience

• BComm, BSc or equivalent
• Experience in the commercial- and integrated management of a multidiscipline information technology environment

Specific Job Skills

• 3 – 5 years’ experience in Networking Environment
• 3 – 5 years’ experience in Microsoft Environment
• 3 – 5 years’ experience in MES Environment (ANSI/ISA95)

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Overview

To support users, equipment, applications, and technologies to maintain high levels of productivity.

Responsibilities

Operational Activities

• Installation and maintenance of end user computing devices.
• Managing and migrating user data, profiles, and applications.
• Installation and troubleshooting of additional applications.
• Provide ongoing support for video conference equipment and projectors and other office collaboration technologies.
• Hardware and software asset management.
• Troubleshoot and perform repairs on problematic end user hardware equipment.
• Troubleshoot and perform repairs on networks, cabling, and VPN connections.
• Provide backup to Network support on access layer changes.
• Manage incidents and requests on call management system.
• Assist user with queries relating to basic computer skills and competencies
• Support system engineers in managing infrastructure services lie endpoint protection and patching.
• Assist production with endpoint devices running manufacturing and Lab equipment.

People Management

• Develop, review and update SOP’s and work instructions in line with the evolution of business unit processes.
• Conduct training, coaching and performance reviews.
• Implement process improvements to reduce lead-times and eliminate non-value-adding activities.
• Collaborate with all stakeholders to generate alternatives and find solutions.
• Familiarise yourself with at all times act in accordance with the company policies and procedures

GMP

• Complete all records and reports timeously and accurately as described in the relevant SOP’s, protocols and associated documentation.
• Comply with GMP/GLP requirements as outlined by company SOP’s and written instructions in all tasks and activities
• Ensure that products are produced, tested and stored according to the required SOP’s and documentation

Health, Safety and Environmental Standards

• Carry out any duty or requirement imposed on the company by the OHS Act and in accordance with your specific SHE appointment
• Report any unsafe or unhealthy situations to SHE representative or Line Manager
• Report any incident to the SHE representative or Line Manager which may affect your health or cause injury

Job Requirements

Background/experience

• Matric/Grade 12/N3 or equivalent
• MCSE certificate an advantage
• CCNA certificate an advantage
• ITIL certificate an advantage
• A+ Certificate an advantage
• N+ Certificate an advantage

Specific Job Skills

• Extensive product knowledge of MS Office and Windows
• Knowledge of troubleshooting End user applications
• Experience in working with ServiceDesk systems
• Ability to do 1st line network support
• Experience with Imaging and management software

Competencies

Interrogating Information

• Making Decisions
• Taking Action
• Managing Performance
• Planning and Organising