Current Vacancies at Aspen Pharma Group

Overview

• Strategic management of local process standardisation, optimisation and transformation to maximise profitability
• Governance, Measurement and improvement of Key Business Process KPIs
• Strategic management and integration of key technologies (SAP, MES, LIMS, Kinaxis) with business requirements and process across functional areas, group and external stakeholders.
• Managing business integration of Group Optimisation Projects rolled into business unit (Integrated Business Planning, SAP upgrades, Master data governance)
• Strategic management of Value Chain optimisation within business unit
• Perform a Business Advisory function for Business Unit Executive and leadership team
• Manage the IT and Digital Technology function for business unit through Project facilitation of specific IT projects, management of Application, Business and Technical Services and financial management according to Aspen Group Standards and Policies.
• Responsible and accountable for IT operating and CAPEX budget for business unit
• IT strategy formulation, prioritization and implementation for business unit
• Managing SLA for both internal and external clients
• Ensure compliance to overall IT governance aligned to group directives
• Delivery of IT Projects

Responsibilities

Business Optimisation, Strategy and Project Governance

• Participate in the development and lead the implementation of the strategic vision and direction for key business projects, as well as all related plans
• Design and lead a structured governance framework for SA OPS technology implementations including process, technology and data
• Manage the standardisation of business processes within SA OPS where possible
• Hold project teams and stakeholders accountable for project deliverables, goal identification, training and development
• Manage the establishment of strategic and business process aligned policies and procedures across SAOPS functional areas
• Manage collaboration and coordination between SA OPS departments to align and optimise processes across the value chain
• Maintain and support positive engagements and enhance issue resolution processes with internal and external customers
• Provide Business Advisory support for the SA OPS SLT
• Strategically support the SA OPS Site executive and Chief of Staff
• Manage SAOPS Operational Excellence Team input into MPP global process ownership and future roll outs
• Drive the data quality, data integrity and data management across the business to enable data to be used as an enterprise asset
• Drives continuous improvement and business optimisation via digital technology
• Participate in business process review, recommending amendments or additions to processes in alignment to blueprint
• Ensure the quality of relationships with unions with a culture of transparency. Support the actions around ER/IR climate.
• Build budget / P & L and ensure management of operational expenses (CAPEX/OPEX)
• Ensure the competitiveness of the factory (COGS)
• Represent the site in regards of all relevant authorities

Financial

• Responsible and accountable for SA Operations IT and Digital Technology budget. 
• Drawing up operational and capital budgets, managing on-going expense, and ensuring the most efficient use of company resources.
• Responsible for the consolidation and co-ordination of operations level IT budget. (Measured by TCO trends, industry benchmarks as well as inter-site benchmarking)
• Measure and Optimise key Value chain KPIs to ensure Business goals are achieved

Customer Service

• Ensure appropriate support for SA Operations in all ICT related requirements. This includes the, provision and management of all IT related infrastructure, desktop support and application support. (Measures of uptime, call resolution, customer perception)
• Facilitate and lead business readiness and change activities across functions
• Guide and review transformation and change management deliverables prior to implementation

Business Enablement

• Participation in IT strategy formulation, prioritizing and implementation.
• Constantly monitors industry trends to identify current and best practice in digital technology aligned to Pharma and Industry 4.0 for transfer into SA Operations

Business Systems

• Implementation and administration of applications and IT systems.
• Participation in IT strategy formulation, prioritizing and implementation.
• Constantly monitors industry trends to identify current and best practice in digital technology aligned to Pharma and Industry 4.0 for transfer into SA Operations

Service Level Management

• Responsible for managing service level with both internal and group clients, as well as service providers, including external vendors and Group IT functions (i.e. SCM, infrastructure, PC sourcing, compliance)

Compliance

• Facilitate all audits and ensure the responding and resolution to findings in these audits
• Ensuring adherence to site and group policies and procedures, information security, data management and responsibility for disaster recovery related to the systems hosted in the Port Elizabeth data centre.
• Responsible for the quality status of all validation requirements of IT systems and infrastructure

Requirements

Skills Required

Background/experience

• Minimum of Bachelor’s degree preferred, ideally in Commerce or Engineering or Information Technology
• 10 years’ related experience with strong project management & finance experience in manufacturing

Specific job skills

• Strong manufacturing financial background displaying a sound commercial sense, along with a broad understanding across the functional areas of manufacturing and related interdependencies, the processes and critical business focus of factory operations
• Utilise data and optimisation techniques to maximise profit across the business
• Solve highly complex technical / business issues, work with broad objectives, apply advanced technical knowledge
• Strategic Planning (ITSP)
• Emerging Technology Monitoring (EMRG)
• Financial Management (FMIT)
• Stakeholder Relationship Management (RLMT)
• Workforce Planning (WFPL) and Resourcing (RESC)

Competencies

• Accountability & Ownership
• Creates the future
• Make good decisions
• Translating Strategy
• Managing Performance
• Investigating Possibilities
• Communicate Effectively
• Deal with ambiguity, embrace change
• Develop talent, teamwork, diversity
• Lead and influence others
• Demonstrate a passion for Aspen

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Description

• Review and approve batch documentation in line with SOP and quality standards.
• Perform lab quality review in line with SOP.
• Provide services according to Production plan.
• Related administrative tasks.

Requirements

Planning and Operational Support

• Oversees work and/ or serve as a lead technical expert.
• Optimize and facilitate implementation of current processes.
• Identify gaps in current policies and procedures.
• Propose changes or improvements to processes, tools, and techniques.
• Provide information for reports, as required by superior.
• Provide analytical support in the absence of the TL.
• Provide support during regulatory audits.

Lab Quality Review

• Perform LQRs according to Production plan.
• Review and approve lab records to ensure pharmaceutical analysis has been carried out as per MOA, direct queries to laboratory.
• Electronic approval of analytical results on relevant software. e.g., Empower
• Evaluate and interpret chromatography data to ensure accuracy of results.
• Review and approve batch documentation compliance with SOPs and quality standards.
• Correct errors in batch documentation, in line with GMP standards, SOPs, and product specifications
• Record all OOS investigations and conclusions, and report to management.
• Provide advice to analysts during laboratory investigations.
• Provide input into SOPs.
• Ensure that products are produced, tested, and stored according to the required SOP’s and documentation.
• Ensure adherence by Analyst/ Tester before release.

Reporting and Record-Keeping

• Document and store data according to SOPs and regulation
• Consolidate information for reports on weekly/ monthly basis.
• Analyse consolidated data and provide recommendations.
• Compile detailed and standardized reports and consolidated documents.
• Initiate deviations once picked up during reviewing.

Skills Required

Background/experience

• National Diploma in Analytical Chemistry with 6+ years’ experience
• Laboratory experience

Specific job skills

• Understanding of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes, and objectives.
• Strong technical knowledge and be competent in the use of all laboratory equipment, software, and techniques.

Competencies

• Interrogating Information
• Following Procedures
• Maintaining Accuracy
• Customer Awareness

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Description

• Monitor and support vendor related activities and technical agreements.
• Qualification of vendors in accordance with organization and regulatory requirements.
• Provide expert support to company and vendors sites to ensure successful regulatory and 3rd party audits.
• Related administrative tasks.

Requirements

Request and review vendor documentation and statements

• Desk Audit Questionnaire
• Nitrosamine Statements
• ICH Q3D statements
• ICH Q3E statements
• BSE/TSE Statements
• Any other relevant documents

Conduct Annual Vendor Risk Assessments

• Conduct API; Primary/Printed Packaging Components and Quality Critical Consumables Risk Assessments as per company and regulatory expectations
• Conduct Excipient Risk Assessments as per as per EU Guideline 2015/C95/02
• Based on the outcome of the Risk Assessments, determine the Minimum Vendor Requirements

Conduct Vendor Classification of Vendor Items

• Review vendor classification documents, including number of batches received and tested, review of deviations, OOS, rejections, etc.
• Review regulatory and statutory compliance of vendors.
• Based on the classification outcome, classify vendor items as not well known, well known, or validated
• Promote or demote vendors based on monitoring outcome.

Conduct Annual Vendor Monitoring

• Review vendor performance in terms of quality metrices such as rejects, deviations, OOS, etc
• Review vendor GMP compliance status
• Review vendor classification and promote or demote as applicable.
• Review and approve changes to audit system.

Skills Required

Background/experience

• Bachelor's degree in science or science related field, with 4 6 years related experience or Post Graduate Degree or Diploma in Science or Science related filed with 1 3 years’ related experience.
• Experience in GMP regulated industry.
• Experience in GMP regulated industry in a QA and auditing role.

Specific job skills

• Extensive knowledge of good manufacturing regulations, quality assurance, and raw material and packaging material
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes, and objectives.
• Ability to interpret raw material and packaging material specifications.
• Project management
• At least 2 years’ experience in vendor qualification practices

Competencies

• Information and data gathering
• Interrogating Information
• Offering insights
• Taking Action

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KEY RESPONSIBILITIES:

Strategic Decision Making

• Market analysis and gathering insights to arrive at strategic intent.
• Develop succinct portfolio/brand strategies with supporting tactical plans in form of a Brand Plan to drive the strategic intent.
• Successful roll out and leading the implementation of tactical plans and monitor the roll out.
• Anticipate future trends in disease management and the market environment. 

Commercial Capability

• Ability to set sales budgets agreed in the business.
• Compile advertising and promotional budget in line with brand strategy
• Ability to manage the cross functional networks and unlock channel opportunites for the portfolio to drive profitable growth.
• Ability to interpret and implement insights drawn from a variety of internal and external data sources.

Sustainable Business Growth and Profitability

• Forecasting accuracy to ensure On Time and in Full delivery of stock.
• Stock management which entails minimizing write-off costs and returns, monitoring and managing distributor and wholesaler’s stock holding as well as backorders.
• Effectively manage and monitor sales as well as promotional budgets.
• Maintaining portfolio profitability through pricing strategies, profit margins and batch MOQ’s
• Assess market potential of opportunities/pipeline with NPL team to successfully implement new products once launch ready.
• Drive launch excellence through effective project management.
• Effectively manage and initiate the required Advertising and promotional campaigns, including effective Omnichannel initiatives to support execution excellence and maximize ROI.
• Initiate robust measurements for tactical execution outcomes to maximize ROI and future commitment decision making. 

Innovation

• Innovative way of thinking to secure a competitive advantage.
• Solution orientated.
• Provide creative direction for brand/ portfolios strategies.
• Pipeline management to secure future portfolio assets with NPL team

Internal and External Customer Interaction

• Drive cross functional efficiencies and collaboration with key stakeholders to deliver on quantitative and qualitative targets to achieve brand/portfolio priorities through engagements.
• Sense of urgency in resolution of customer queries
• Quality assessments of portfolio/ brand strategy and tactical implementation through infield visits to obtain required intelligence and insights.
• Optimize Training department engagements to ensure field force is fully equipped and aligned with strategic and execution requirements.

Requirements

Skills and Competencies

(The abilities that the individual needs to perform this role effectively)

• Commercial Acumen
• Analytical skills
• Project management
• Networking ability
• People skills
• Ability to perform under pressure.
• Initiative-taker and self -motivated
• Sense of urgency
• Prioritizing and planning
• Verbal and written communication skills
• Aptitude for continuous learning
• Influential and impactful presentation skills
• Adaptability and flexibility in a changing environment

QUALIFICATION & EXPERIENCE:

• Matric
• Relevant Post matric Marketing/Health Science qualification
• 2-3 years Brand management experience in the pharmaceutical industry
• 2-3 years Sales experience in the Pharmaceutical industry
• Applicable industry knowledge
• Financial literacy
• Proficiency in Excel, PowerPoint, Outlook, and Word
• Ability to work on Microsoft Power BI models is advantageous.

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JOB PURPOSE:

This position is a field-based position for the Oncology therapeutic area within the Medical Affairs organization, to maximize Aspen’s value propositions through first-class medical and scientific projects, services and expertise, with key scientific customers. The MSL will interact with healthcare professionals to communicate and advance the scientific platform as aligned with Aspen’s corporate goals and objectives. The MSL is an integral position in assuring accurate, clear, and valued information regarding our scientific platform is communicated to multiple levels within the medical community. The MSL will communicate complex cutting-edge scientific information and research concepts to healthcare decision makers. The role may also include clinical and pharmacoeconomic value discussions with payers and formulary decision makers. The MSL is also responsible for training key stakeholders (both internal and external) to ensure they are updated on new data. In addition, the MSL will provide insights and feedback based on field interactions and scientific support consistent with Aspen’s corporate goals and objectives.

RESPONSIBILITIES:

• Establish and maintain an in-depth scientific and clinical understanding of related clinical area
• Identifies, develops and maintains collaborative relationships with current and future KOLs, scientific experts, cooperative study
• groups  and study sites 
• Engage in scientific exchange with healthcare professionals to communicate and advance the scientific communication platform, as aligned with Aspen’s corporate goals and objectives
• Communicate complex, cutting edge, scientific information and research concepts to healthcare professionals
• Respond to unsolicited inquiries consistent with the MSL compliance standards
• Provide and/or present field observations and insights to internal stakeholders
• Delivers targeted internal training for selected topics (e.g. study update, congress news, latest scientific developments)
• Supports Head MSL/Medical Manager in developing local territory Medical tactics 
• Execute scientific engagement plan according to annual MSL goals and metrics
• Develop and implement local KOL plans in line with scientific engagement plan
• Develops required qualitative and quantitative reports; collates competitor information
• Implements and disseminates high quality medical and scientific  educational programs
• Attend and support congress activities as aligned with strategy
• Ensures society engagement: MSL support of international, regional and local congresses
• Identify / recommend sites for Aspen’s partners clinical trials in conjunction with clinical development organizations 
• Manage the field activities related to the submission and execution of Investigator Supported Studies (ISS) in line with Aspen’s existing policies
• Provide scientific support, consistent with the MSL compliance standards, for commercial, corporate accounts, and other matrix colleagues who may forward HCP inquiries
• Discusses scientific value messages, clinical outcome,s and patient benefits with KOLs, hospital pharmacists and local payers in close collaboration with KAM/Market Access 
• Lead and/or participate on committees or project teams that support MSL strategies and tactics as delegated by Brand Team
• ~80 % travel/infield
• Ensures conduct of work in line with compliance regulations

Requirements

QUALIFICATIONS:

• Medical or scientific education or experience from similar positions
• Advanced degree (MBChB, PhD) preferred or strong demonstration of equivalent combination of relevant educational and professional training

EXPERIENCE:

• Minimum 2 years of experience in industry, or a related scientific field in academia
• Experience affiliate Medical Department or Clinical Development
• Willingness to travel; possesses valid driver’s license
• Experience with clinical study management and conduct
• Medical / scientific research experience
• Network of customer contacts

KNOWLEDGE:

• Scientific expertise in the therapeutic area, related products, disease state, and interested in latest discoveries 
• Knowledge of value messages, clinical outcomes and patient benefits for the products
• Has solid understanding of country health care system and decision-making, stays on top of changes 
• Demonstrates strong project management and presentation skills
• Knowledge of commercialization and business practices
• Good knowledge of clinical research, drug safety, legal and compliance environment
• Willingness to continuously expand medical, scientific, market, and industry knowledge

COMPETENCIES AND BEHAVIORS:

• Is approachable and trustworthy, builds constructive and effective lasting relationships
• Acts with customers in mind
• Defuses even high-tension situations comfortably, sees issues as opportunities
• Plans project by setting objectives and goals, and time lines
• Identifies roadblocks and overcomes them; completes deliverables on time
• Presents convincingly and confidently in a variety of formal settings; adjusts to audience with ease, brings the message across
• Attentive and active listener, hears people out
• Communicates pro actively and constantly keeps all internal and external stakeholders updated
• Creates a climate in which people want to do their best and like working 
• Inspires and enthuses others
• Acts as role model by being open, honest, cooperative and living the Aspen Values
• Can find common ground and gain co-operation smoothly
• Uses scientific expertise to influence medical practice
• Is action-oriented, turns decisions into practice
• Is able to effectively work in the matrix
• Can leverage the collaboration with other functions such as Commercial and Access

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Overview

• Drive the implementation of production, activities and take accountability for the meeting of production targets.
• Problem identification and solution engineering.
• Ensure OTIF delivery within cost budgets.
• Lead and drive outputs of the following units: Production, QC, HR, Production planning and Maintenance.

Responsibilities

Operational Activities

• Lead and inspire all the personnel on the site – with a specific focus on the management team to ensure that they are aligned on the outputs and service promised in line with an agreed plan.
• Drive the site strategy deployment process.
• Define the vision, mission and objectives for the site and make sure that there is a high level of engagement from all employees.
• Responsible for management of manufacturing operations on the site
• Make sure that technological upgrades of site are encouraged and duly implemented (through proper coaching, training, better skills, and better behaviours).
• Ensure all demand is appropriately planned to meet supply requirements.
• Lead a performance driven organization.
• Ensure compliance at the site. Keep improving the quality standards and ensure strong compliance standards with external regulators. Ensure compliance in the areas Quality, SHE, Legal, IT, HR, Financial and others critical areas for the manufacturing business.
• Understand the commercial relevance of the sites output in terms of the customers, supply chain and products manufactured at the site.
• Develop people on site to ensuring a strong talent pool, actively participate in talent management activities.
• Ensure all managers can deliver on their responsibilities.
• Ensure the quality of relationships with unions with a culture of transparency. Support the actions around ER/IR climate.
• Build budget / P & L and ensure management of operational expenses (CAPEX/OPEX)
• Ensure the competitiveness of the factory (COGS)
• Represent the site in regards of all relevant authorities

Production Planning and Process Management

• Ensure operational excellence with regards to safety, quality, and productivity of the Focus Factory, and its ability to deliver high levels of service to internal and external customers.
• Manage people, materials, equipment, business, and manufacturing processes to deliver Factory performance objectives, as measured by factory KPI’s.
• Ensure compliance with policies/procedures for shift rotation, vacation scheduling, and training to meet business needs including peak production periods.
• Manage the development and implementation of daily production schedule to ensure high levels of OTIF to internal and external customers.
• Ensure effective implementation of new technology and products.
• Implement TPM and other continuous improvement programs.
• Develop and implement CAPEX budgets.
• Ensure integrity of business processes related to finished goods inventory replenishment, and new product introductions.

 Governance, Risk and Compliance

• Ensure adherence and compliance to regulatory requirements.
• Ensure that appropriate validations are completed as per validation requirements and schedule.
• Initiate and set targets, and review GMP, quality and training needs.

Requirements

Skills Required

Background/experience

• Minimum of Bachelor’s degree preferred, ideally in Pharmacy/ Engineering/ Chemistry with 10 years’ related experience
• Pharmaceutical manufacturing experience
• Project Management experience
• Managing a Strategic Production site
• Proven Leadership Capability and Managerial Experience

Specific job skills

• Strong working knowledge of Pharmaceutical Manufacturing
• Problem Solving and Solution Engineering
• Pharmaceutical standards and Compliance requirements
• Coaching Leadership and mentoring
• People and Departmental management
• Deep understanding of quality, operations, and logistics

Competencies

• Customer Awareness
• Translating Strategy
• Making Decisions
• Managing Performance