Aspen has a proud heritage dating back more than 160 years and is committed to sustaining life and promoting healthcare through increasing access to its high quality affordable medicines and products. Aspen has a market capitalisation of approximately US$10 billion, is the largest pharmaceutical company listed on the JSE Limited (share code: APN) and rank...
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Job Description
Coordinate quality activities, including:
- Interpret and implement quality procedures, standards and specifications
- Preparation of regulatory audits
- Action all audit related activities and responses
- Pro actively initiate continuous improvement activities to improve quality compliance under the guidance of the QS Management
Job Requirements
Audit Readiness and Performance
- Participate in site walkabouts and prepare department owners for upcoming audits
- Compile documentation required for external audits
- Review compliance status of the facility and highlight risks to the quality team
- Prepare teams and documentation prior to presentation to the auditors
- Co ordinate activities and documentation requests during site audits
Audit CAPA Management
- Liaise with department owners to compile audit responses to external audit observations, according to the required standard
- Maintain status updates of the audit CAPA actions for both internal and external audits
- Timeously prepare external audit responses for submission
Operational Support
- Track continuous improvement actions identified and ensure effective implementation thereof
- Assist with preparation and review of documentation requested by external customer and regulatory bodies
- Take part in project risk assessments for introduction of new products/facility changes
Policy, procedure and document management
- Provide input into policies and procedures with regards to latest authority expectations
- Draft and maintain SOPs relevant to the functions performed by the department
- Review site procedures for compliance to regulations and Group Operations Quality Compliance
Review and reporting
- Compile audit CAPA update reports for submission to external and internal stakeholders
- Update the Quality CES audit matrix with the latest status of observations
Background/experience
- Minimum of Bachelor’s Degree (BPharm) or relevant scientific qualification
- Knowledge of regulatory guidelines
- Minimum 4-6 years’ related work experience
- Pharmaceutical manufacturing experience
- QMS experience is advantageous
- Regulatory audit experience is advantageous
Specific job skills
- Strong working knowledge of pharmaceutical manufacturing and corrective action programs
- Pharmaceutical standards and compliance requirements
- People skills and working well with others
- Report writing skills
Competencies
- Offering Insights
- Taking Action
- Information gathering
- Interrogating information
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Job Description
- Compilation of documents required for audit purposes.
- Logging and tracking of audit CAPA commitments.
- Preparation of QA Compliance related documentation where requested.
Job Requirements
Process improvement and support
- Carry out continuous improvement activities under supervision of the QS management team
- Tracking of continuous improvement and compliance activities, including risk assessments
- Maintain SOPs within the QS department
Operational QS Support
- Assist with document collation requests for external customers and regulatory bodies as requested by QS Management
- Assist with data collation and report writing in the QS department
- Audit Activities
- Assist with the documentation requests prior to- and during GMP audits
- Communicate audit requirements, recommendations and processes with relevant departments
- Gather evidence for completed CAPA commitments
Reporting and analysis
- Assist with data generation and trending of data for analyses and reporting
- Compile initial audit response reports for review
- Consolidate information for reports specific to area of responsibility
- Track all audit external and internal CAPA commitments for QSMR reporting
Planning and procedures
- Plan for and prioritise own tasks and responsibilities, within standards and procedures, to fulfil work requirements
- Determine resource needs of own area of work
- Optimise current processes
Background/experience
- 2 to 4 years’ related work experience
- Learnership and registered PMA
- Quality Systems experience
Specific job skills
- Report writing skills
- Working knowledge of local registrations and regulations and of international regulations/guidelines concerning GDP/GMP, QA
- Understanding of the pharmaceutical manufacturing and corrective action programs, pharmaceutical standards and compliance requirements
- Attention to detail
- Sense of urgency and prioritisation
Competencies
- Customer Awareness
- Following Procedures
- Interrogating Information
- Organisational Citizenship
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Overview
- Head of Engineering is expected to provide technical strategic leadership for the East London factory and drive technical excellence by leading the engineering to evaluate existing and new infrastructure, processes and improves capabilities, efficiency and productivity in all areas of manufacturing at the East London factory.
Responsibilities
Planning and Unit Management
- Provide timely technologically efficient support to the site for manufacturability, product cost, workflow, quality and safety.
- Oversee the maintenance of all process equipment and facilities, optimizing machine efficiencies
- Provide technical expertise including engineering support in the existing site as we all as new capital construction / installation activities
- Coordinate outside contract support for projects. Direct the operation of the site utilities, including technical responsibility and infrastructure maintenance for support of all manufacturing, laboratories, warehouses and office areas
- Confer with vendors to determine engineering specifications and arrange for purchase of equipment, materials or parts and evaluate activities according to safety, ergonomic specifications and quality standards
- Prepare, execute and oversee capital projects and budget as well as Plant Operating budget
- Oversight and management of the engineering stores ensuring a critical spares and equipment strategy
Engineering Services
- Design, implement and manage the maintenance of equipment, machinery, buildings, breakdown services, contractors and equipment
- Oversee and manage all capital expenditure projects according to time, cost and quality requirements
- Oversee and manage the design of Engineering Maintenance System
- Oversee and control all Engineering deviations in agreement with Senior Managers
- Manage site energy efficiency
- Manage validations, calibration and preventative maintenance program
- Oversee and manage all site utilities and report on programs
- Maximise use of equipment and technology
- Oversee design and implementation of SOPs for all equipment and utilities
- Identify training needs to ensure user competence is current
- Manage GMP and any other compliance requirements as applicable
- Manage and ensure that the plant equipment and facilities are 100% compliant with the OHS Act.
Governance, Risk, Safety & Compliance
- Oversee compliance within strategic and operating guidelines and policies for unit
- Ensure recordkeeping complies with legal requirements and provide input into changes to policies in this regard
- Provide recommendations for development of risk-based compliance systems in order to improve overall compliance performance of the organisation and unit
Job Requirements
Skills Required
Background/experience
- Bachelor's Degree in Mechanical / Electrical Engineering with 15 years’ related experience; Masters qualification is advantageous
- Engineering Certificate of Competence (Government ticket) GCC/GMR2?
- Pharmaceutical manufacturing maintenance experience
- Leadership experience
Specific job skills
- Ability to read, write and interpret technical procedures, blue-prints, diagrams, requirements and business correspondence
- Knowledge of production processes and maintenance activities, control and calibration systems
- Knowledge of material handling, manufacturing equipment and processes and tooling
- Lean management
- World class manufacturing excellence
- Knowledge of pharmaceutical manufacturing, standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives
Competencies
- Interpreting and Internalising Information
- Interrogating Information
- Managing Performance
- Creating Clarity
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Job Description
Overview
- Manage and support production processes and outputs
- Long term production and shift planning
- Problem identification and solution engineering
- Manage and guide production staff through team leaders
- Performance management of direct reports, monitoring of performance management within department
- Reviewing and approving production instructions, validation and qualification of manufacturing equipment and tools
Responsibilities
Planning and Unit Management
- Provide technical and operational input into processes, procedures and policies
- Coordinate the communication, management, and implementation of strategic plans and monitor implementation
- Build and maintain relationships with internal and external stakeholders
- Develop, implement, and monitor Focus Factory operating budgets
- Ensure availability and optimal allocation of resources within unit
- Perform HR functions for optimal management of unit
- Empower subordinates through training, information sharing, coaching, feedback, appraisals, and delegation, to ensure the development of people, teams, and organisational capabilities
- Attend production, quality and safety meetings
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 & 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
Job Requirements
Skills Required
Background/experience
- Bachelor’s degree preferred, ideally in Pharmacy/ Engineering/ Chemistry with 10 years’ related experience
- 3 – 5+ years’ experience in a management role
- 5 – 8+ years’ experience in a pharmaceutical manufacturing
- Project Management experience
Specific job skills
- Strong working knowledge of pharmaceutical 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
- Offering Insights
- Making Decisions
- Managing Performance
- Customer Awareness
- Developing Others
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OBJECTIVE OF ROLE
- The Specialty Sales Representative acts as the primary customer contact and is responsible for implementing marketing strategy and promoting Aspen products as led by the Regional Sales manager, in order to meet specified sales targets through a customer centric approach
KEY RESPONSIBILITIES
- Achieve sales targets (Sales vs budget)
- Constant monitoring and driving sales from customers, scripting from doctors and sales from pharmacies in order to meet set targets. Sales to be driven at customer level by affective scientific detailing and use of marketing material
- Plan - Pre-call planning on Veeva on weekly basis
- To be done weekly on Veeva and daily prior to the customer call. This will ensure that you are prepared for the call. If you have a manager working with you for the day, your pre-call planner must be emailed to the relevant manager, the evening before. Review the available data (Impact Rx, Shortfall reports, SSD, Swift, Power BI, etc.).
- Achieve Call Rate and CPA objectives
- See the required number of customers on a daily basis to achieve call rate and at the correct frequency to achieve call plan adherence.
- Capture daily calls and activities on Veeva
- Synch to be done twice a day, or as specified by the business. Final Synch to be done after the last call for each day.
- Conduct Doctor or pharmacy activities in line with compliance and regulatory standards
- Complete the required number of pharmacy trainings and Doctor/pharmacy Meetings as required per business and territory requirements
- Effective scheduling and attending appointments and activities with healthcare practitioners (Doctors, Nurses & Pharmacies etc.) in order to influence sales and meet sales targets.
- Implementing strategies to drive sales and growth in territory
- Maintain a solid working relationship with customers and colleagues.
- Territory and customer analysis in order to identify gaps and opportunities to be acted upon.
Job Requirements
EDUCATIONAL REQUIREMENTS
- Matric
- A valid driver’s license
- Tertiary qualification in Bio Science, Chemistry or related fields.
KNOWLEDGE & EXPERIENCE REQUIREMENTS
- Minimum 3 to 5 years’ experience in the Immunology Specialty sales environment
- Current relationships with HCP’s in territory are an advantage
- Product knowledge on competitor products within the therapeutic market (Biologics an advantage)
- Comprehensive understanding of business procedures.
- Strong clinical ability to enable in-depth clinical discussions
- Effective territory management and optimization.
SOFT SKILLS AND COMPETENCY REQUIREMENTS
- Analytical and Interpretation skills – Being able to analyse Aspen in house data and external data sources
- Clear communication skills both verbally and written.
- Strong capabilities in logical reasoning in order to address and resolve queries, issues and objection handling
- Influencing and negotiation skills.
- Forward thinker with the ability to work independently as well as to work as a team player.
- Good administrative skills in order to ensure that tasks are completed accurately and timeously.
- Driven individual who is a self-starter and able to solve problems and gathers insights to feed back to the business.
- Active listening skills
- Ability to work under pressure.
- Excellent interpersonal communication, presentation, and negotiation skills
- Numerate, analytical, high attention to detail, able to prioritize.
- Execution and understanding of set budgets
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OBJECTIVE OF ROLE
- Maximizes sales and market share in South Africa, by driving sales activity and providing leadership & coaching to a national Renal-Cardio sales team
KEY RESPONSIBILITIES
- Translates Aspen brand strategies into sales plans
- Analyses the sales performance of the relevant brands in the territory and identifies key levers for action
- Keeps business unit team informed of any market changes / competitor activity relevant to strategy implementation and development
- Ensures execution of the Marketing/Commercial tactics by development of territory plans (Plan of Actions) with team members
- Manages approved budgets to ensure appropriate allocation of resources to meet the plan and keep financial control
- Plans, allocates and monitors sales team expenses budget to ensure budgetary control
- Tracks progress of marketing messages and programs
- Monitors implementation of plan of actions throughout sales cycles and ensures budget spend within agreed time, costs, compliance and quality parameters
- Monitors, evaluates and acts on sales field force metrics and standards to maximize sales force effectiveness from a quantitative and qualitative perspective
- Builds and develops a high performing sales team
- Recruit and select candidates for vacancies and effectively on-board new hires
- Coaches and motivates sales team members to achieve/exceed territory goals and optimise individual and team engagement
- Conducts annual and ongoing performance reviews and capability assessment within the framework of Aspen’s performance management process
- Develop individual team members to continuously improve overall level of performance in their role and for future development
- Drives a culture of ownership and accountability
- Ensures data driven decision making
- Supports the team members on external key customer visits as needed
Job Requirements
EDUCATIONAL REQUIREMENTS
- Must have a Matric
- Relevant tertiary qualifications
KNOWLEDGE & EXPERIENCE REQUIREMENTS
- Minimum 3-5 years sales experience within a multinational pharmaceutical company
- 3-5 years’ experience specialist disease area
- 3-5 years’ experience as a Pharmaceutical Sales Manager
- Experience in Renal-Cardio portfolio
- Financial and budgeting skills and experience
- Computer Skills (MS Office programs) and especially excel/Power BI
SOFT SKILLS AND COMPETENCY REQUIREMENTS
- Selling and coaching methodology expertise
- Excellent communication and presentation skills
- Strong leadership and people management skills
- Analytical skills and strategic thinking
- Proficient in excel/PowerPoint/Word/Power BI/Repwise or Veeva
- Relevant pharmaceutical Market knowledge
- Strong customer and patient orientation; science-based and marketing minded; negotiation and sells skills
- Operational excellence: management skills, planning, prioritization, decision making, objective setting, meeting management and plan execution
- Role model for others in line with Aspen Values
- Fluency in English, both oral and written communications
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Job Description
- The Key Account Manager identifies, analyses, and drives business opportunities for the Aspen portfolio. The role is responsible for achieving sales targets at both regional and national levels by developing and executing commercial plans of action. This includes creating and maintaining optimal patient access in hospitals, pharmacies, and other relevant stakeholders to ensure sustainable and profitable growth.
- This role will report to the Commercial Manager, NL
Job Duties:
Strategic Planning & Execution
- Develop and implement strategic commercial plans to maximize Aspen’s portfolio performance.
- Prepare and execute territory/regional commercial plans that deliver profitable sales and optimal patient access.
- Contribute proactively to commercial and marketing plans
Sales & Market Growth
- Achieve sales targets and market share objectives in assigned region and support national goals.
- Implement strategies and tactics to ensure market penetration, market share, and sales growth.
- Identify new business opportunities and expand Aspen’s product usage with existing & potential customers.
Customer & Stakeholder Engagement
- Build and maintain strong relationships with key customers, hospitals, pharmacies, and other stakeholders.
- Build advocacy for the portfolio and foster partnerships to clear access hurdles.
- Negotiate contracts and pricing agreements to maximize profitability and introduce new agreements.
Market Intelligence & Analysis
- Monitor market trends, competitor activities, and regulatory changes to inform strategy.
- Apply targeting and segmentation to prioritize stakeholders and accounts, leading to actionable plans.
Cross-functional Collaboration
- Coordinate with internal teams to resolve client issues and deliver tailored solutions.
- Collaborate with medical, regulatory, and marketing teams to support product launches and campaigns.
- Actively participate in projects and internal initiatives.
Execution & Accountability
- Take full accountability for sales and access in territory/region.
- Drive strong execution of commercial activities with an investigative mindset for continuous customer understanding.
- Be proactive, embrace change, and utilize commercial opportunities as they evolve.
Job Requirements:
- Bachelor’s or master’s degree in business administration, Marketing, Life Science or related field.
- 2-3 years’ experience in pharmaceutical sales or marketing, or account management.
- Strong knowledge of the Dutch health care system and hospital procurement processes.
- Strong business acumen to assess profitability/effectiveness of commercial opportunities
- Familiarity with OTC, Women’s Health and/or Anaesthesiology is an advantage.
- Fluent in Dutch and English
Method of Application
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