Vacancies Open at Aspen Pharma Group

Description

Overview

• Manage and supervise the manufacturing/packing of products
• Manage production frontline staff and drive shift production performance against key metrics
• Ensure production problems are identified and solved
• Deliver planned production output and achieve plan adherence goal
• Deliver operational efficiencies and reduce unplanned downtime
• Performance management of direct reports, monitoring of performance management within section 
• Support pharmaceutical responsibility, if a qualified pharmacist

Responsibilities 

Planning and Section Management

• Provide input into operational planning of section, and prioritisation of objectives
• Provide input into, interpret and execute policies and procedures
• Provide input into and manage budgets and resource requirements for section
• Plan daily and weekly activities of section
• Provide daily coaching and supervision for section
• Manage staff performance to achieve right efficiency, good quality and SHE goals through company performance management
• Implement top loss and waste management programs, to achieve targets

Production Preparation

• Monitor the execution of production plans and take corrective measures where necessary
• Obtain support from Functional Heads to meet Production targets, where required
• Develop and implement contingency plans to manage risk
• Prepare shift and overtime schedules
• Conduct pre-shift and handover meetings
• Plan changeovers with Engineering and Maintenance to ensure operational efficiency
• Review equipment/ machines on shift to ensure optimal efficiency
• Ensure that production score boards are updated daily

Compliance Checks

• Ensure GMP and GDP compliance of Production operations
• Monitor room performance to compliance requirements
• Perform checks to ensure correct setup and operation of equipment and cleanliness of Plant as per SOP

Governance & Risk

• Provide input for improvement of risk-based compliance systems
• Monitor implementation and correct own and/or team compliance with legislation, policies and procedures

Requirements

Background/experience

• National Diploma in Engineering/ Chemistry/ Operations with 5 years’ related experience
• Pharmaceutical manufacturing experience
• Project Management experience
• Supervisory experience

Specific job skills

• Advanced knowledge and understanding of Pharmaceutical manufacturing, TPM/Operational Excellence and Lean Manufacturing
• Problem solving and solution engineering
• Pharmaceutical standards and compliance requirements
• Coaching, leadership and mentoring
• Ability to interpret and implement policies, processes and objectives

Competencies

• Managing performance
• Planning and organising
• Meeting deadlines
• Finalising outputs
• Taking action

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Description

Overview 

• Provision of business support on all aspects of the area’s work
• Coordination and execution of administrative functions within the Steriles Production areas
• Data analysis on shifts/ day performance for responsible areas including OEE, UPDT, SHE, quality, cost and absenteeism KPIs
• Update daily critical KPIs and reports to feedback to line manager

Responsibilities

Administrative support

• Provide input into work activities and priorities for the unit
• Organise and schedule meetings and monitor adherence to schedules
• Coordinate project and office services
• Perform advanced administrative, operational, customer support and computational tasks
• Prepare, compile and release documentation to external departments
• Update, edit and/or format SOPs when required
• Update production target board as required
• Perform shift stock take after each production shift
• Attend shift meetings
• Order/ buy stationery and consumables as and when required
• Perform any other administrative tasks related to work area as and when required
• Provide support in audits and pre-audits of batch record documents as per SOP

Reporting and record-keeping

• Assist in the gathering information required for reporting
• Compile standardised reports and consolidate documents
• Maintain and update records and systems as required
• Retrieve supporting documentation and records to facilitate and support query resolution

Stakeholder relations

• Communicate with internal stakeholders to achieve work objectives, maintain relationships and to assist and convey information

Requirements

Background/experience

• Grade 12
• 1 to 3 years’ administrative experience

Specific job skills

• Broad working knowledge of concepts, terminology and specialised admin requirements to support Production area

Competencies

• Information gathering
• Articulating information
• Planning and organising
• Meeting deadlines

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Description

Overview 

• Prepare, clean, and inspect work areas and equipment.
• Handle and stage raw materials.
• Sample work area(s) and equipment for contamination.
• Sanitize drains and pipes to avoid contamination.
• Related administrative tasks
• Responsibilities

Operational Support

• Execute production activities within established policies, practices and guidelines, as well as established quality and safety standards
• Optimise own work processes
• Identify gaps in current policies and procedures
• Facilitate implementation of processes in own area of work

Inspections & Verifications

• Perform visual inspections of production area(s) and equipment
• Perform pre-production checks such as environmental checks, scale checks, and equipment pre-checks as per BMR, SOP and product specifications
• Verify scale and measuring equipment performance

Material Handling

• Dispense, transfer, weigh and collect raw materials for processing
• Ensure raw materials are staged for processing, in line with requirements

Production Preparation

• Set up the room and IBCs for production activities
• Prepare solutions for production activities as per SOP

Routine Support Tasks

• Clean work area(s) and equipment before and after processing of materials as per SOP and cleaning checklist
• Perform routine equipment checks and transfer of equipment
• Collect samples of production area and equipment for testing
• Control contamination in area by flushing drains and pipes
• Assist with sorting of defected products and discard/ minimise waste
• Provide information to assist with campaign preparation
• Identify and report on operational problems out of specification

Reporting & Record Keeping

• Complete batch record labels
• Complete Overall Equipment Effectiveness (OEE) sheets
• Perform half-hourly inspections of production area(s)
• Attend shift meetings
• Provide information for completion of reports
• Complete and consolidate standard documents
• Maintain and update records and systems as required

Requirements

Background/experience

• Grade 12 or Matric Equivalent Certificates (NQF Level 4) with 0-2 years’ related experience
• Manufacturing experience

Specific job skills

• Basic technical knowledge of Pharmaceutical production processes, procedures, systems and equipment.
• Basic understanding of Pharmaceutical standards and compliance requirements

Competencies

• Finalising outputs
• Following procedures
• Taking action
• Information gathering

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Description

Job purpose

• Tactical and Operational role in the digital technology organization and is accountable for the provisioning, control and improvement of Application and Business Services to meet customer business requirements.
• This includes providing end user support, end user training, contributing to Knowledge Base, identifying and implementing Continuous Service Improvement opportunities, while adhering to agreed service level agreements.

Responsibilities

Application Support

• Provide Application Support to end users of IT systems used in Manufacturing and related departments.
• Investigating and resolving issues
• Providing guidance or training to users — including enhanced levels of support following new/updated software releases
• Devising permanent or temporary corrections and workarounds for faults
• Adhering to established safety, security and quality standards.
• Capturing user feedback for subsequent analysis to inform future application development.
• Updating documentation
• Maintaining application data
• Perform systems administration on the relevant IT systems.
• Ensures compliance to relevant company policies including but not limited to software licensing, access management, information management, information security, etc.
• Maintain the validated state of the IT systems in alignment with Computer System Validation (CSV) policies and procedures.
• Participates in the successful delivery of IT Projects to implement, change, test and/or upgrade the relevant IT systems.

Technical and Support Documentation

• Assist to update technical and support documentation through drafting content relevant to IT services in Standard Operating Procedures (SOPs) and Knowledge Base (KB) articles.
• Contributes to compilation of User Requirement Specifications (URS), Risk Assessments (RA), Change Requests (CR) within the context of the overall Application Lifecycle Management
• Assist with business SOP updates relevant IT systems implementation.
• Clarifies detailed content requirements with customers and representatives of the intended audience.
• Designs, creates, controls and evaluates moderately complex subject matter.
• Makes informed decisions about the best way to present information to an audience.
• Produce knowledge base articles that are accurate, current, relevant and easily understood by the intended audience.
• Contributes to knowledge management systems to meet business needs.
• Supports others to enable them to complete knowledge management activities and form knowledge management habits.

 Incident Management

• To respond to reported incidents, minimizing the negative impacts and restoring service as quickly as possible. Investigating and resolving problems that have occurred or could occur in delivering a service. Assessing risks associated with proposed changes and ensuring changes to products, services or systems are controlled and coordinated.
• Handle incidents according to agreed procedures, investigate causes of incidents and seek resolution. Escalate unresolved incidents.
• Facilitates recovery of processes, following resolution of incidents. Documents and closes resolved incidents, contributes to testing and improving incident management procedures.
• Initiate and monitor actions to investigate and resolve problems in systems, processes and services, determine problem fixes and remedies.
• Collaborate with others to implement agreed remedies and preventative measures and support analysis of patterns and trends to improve problem management processes.
• Assess, analyze, develop and implement changes based on requests for change including adequate version management and methods to report on the lifecycle of change requests.
• Identify problems and issues and recommend corrective actions.

IT Service

• Contribute to provisioning of IT services to agreed service levels and documenting and logging all activities performed.
• Monitors and logs the actual service provided, compared to that required by service level agreements.
• Liaises with stakeholders to help them plan for a deterioration in service and/or breaches of service level agreements.
• Engages with stakeholders to confirm that products developed meet the service acceptance criteria and are to the required standard.
• Provides input into change control processes.
• Identifies opportunities to improve service delivery / Continuous Service Improvement (CSI)

Training

• To provide guidance or training to users — including enhanced levels of support following new/updated software releases – through structured curricula, transferring of knowledge, developing skills and changing behaviours using a range of techniques, resources and media
• Contributes to delivery of aspects of user curricula e.g. end user training role-based content creation.
• Applies good practice in learning content design, development, and delivery.
• Assists with maintaining user competence through delivery of training by observing learners perform practical activities and work and providing assistance within routine enquiries and escalation where needed.
• Assist with hyper care and user adoption support.
• Supports changes to work practices to support capture and use of knowledge.

GxP Requirements

• Perform all duties in compliance with the relevant GxP and cyber security guidelines, standards, policies, and procedures.
• Ensuring compliance with relevant guidelines and legislation through adherence to defined Standard Operating Procedures and other ways of working.
• Identify gaps in procedural documentation and suggest improvements where required.
• Monitoring violations of security policies, analyzing relevant logs, alerts and events
• Responding to incidents according to procedures and maintaining the related security records and documentation

Requirements

Skills Required

Background/experience

• Tertiary Qualification (Diploma or Degree) in IT or related Business qualification
• Current industry certification (ITIL) / training will be an advantage.
• 3 – 5 years’ experience in the relevant business area e.g. Pharmaceutical Manufacturing (Production / QA / Technical Support) or 1 – 2 years’ experience in providing application support and/or systems administration Working in a Pharmaceutical / GxP regulated environment.
• Experience in system administration / IT support experience / Key User responsibility.
• Experience and sound knowledge of service incent and request management methodologies.
• Experience in content authoring and user training and on-boarding will be an advantage.

Specific job skills

• Comprehensive understanding of pharmaceutical testing methods, laboratory processes and Level 4 skills to enable Application Support, Incident Management, Problem Management, Service Acceptance
• Level 3 skills to apply in Quality Assurance, Acceptance testing, Organizational change management, Testing, Content management, Knowledge management, Security operation, and Change Control,
• Level 2 skills to assist in Service level management, Learning delivery and Teaching.
• Working knowledge of PAS-X Manufacturing Execution System (MES), StarLims Laboratory Information Management System (LIMS), Aveva / Wonderware System Platform, and/or SAP S4/HANA applications used in manufacturing of Product.

Competencies

• Business Understanding
• Accountability/ Ownership
• Effective Communication Skills
• Take action with integrity.
• Self-directed
• Accuracy