Job Vacancies at Aspen Pharma Group

Objective: 

To promote and generate sales on key product portfolios to pharmacies on both ethical and generic ranges. In addition to mentioned objective, the position will also be responsible for building and maintaining strong business relationships with pharmacy decision makers, in order to drive net sales revenue.

KEY RESPONSIBILITIES

• Achieve and exceed set sales targets. (Sales vs Budget)
• Constant monitoring  and driving of 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 RepWise and daily
• To be done weekly on Repwise 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, Z-more reports, Shortfall reports, SSD, Power BI and Swift 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 Rep Wise.
• Comms to be done, or as specified by the business. Final Comms 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 activities as required per business and territory requirements

Requirements

Knowledge:

• Proficiency in Microsoft applications
• A sound understanding of the pharmaceutical industry.
• Comprehensive understanding of business procedures.

Skills and Attributes:

• Effective scheduling and attending of appointments and activities with healthcare practitioners (Doctors & Pharmacies etc) in order to influence sales and meet sales targets.
• Implementing of 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.
• Excellent analytical skills to review available data.
• Clear communication skills both verbally and written.
• Strong capabilities in logical reasoning in order to address and resolve queries and issues.
• Influencing and negotiation skills.
• Forward thinker with the ability to work independently as well as to work as a team player.
• Good administrate skills in order to ensure that tasks are completed accurately and timeously.
• Strong work ethic.
• Establishes and maintains positive relationships (mutual trust and respect) with customers and other stakeholders.
• Good product knowledge and the ability to utilize detail material with the correct scientific messaging in order to drive sales.

EDUCATION & EXPERIENCE

• Matric
• A valid driver’s license.
• Tertiary qualification or certified sales profession certification would be an advantage.
• Proficiency in Microsoft applications
• Minimum 2 or 3 years proven track record in a Respiratory sale environment.

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Description

• Facilitate and supervise validation exercises.
• Provide technical support, process control and process improvement activities to support validation activities.
• Assist with validation activities.
• Performance management of direct reports.

Requirements

Planning and Section Management

• Execute and implement policies and procedures.
• Provide input into budget and resource requirements for section.
• Provide staff with day-to-day direction and tasks.
• Support Validation Officers through training, facilitating and problem-solving activities.

Validation

• Develop, implement, and review validation plans, SOPs, and protocols to ensure continued compliance at all times.
• Coordinate validation activities with QC and Production
• Oversee the completion of validation activities according to validation plans/ schedule.
• Evaluate risk from executed validation protocols.
• Investigate deviations from validation protocols, identify root causes, and develop and implement CAPA plans.
• Assist with review of re validation plans.
• Maintain and audit compliance of validation activities.
• Ensure test equipment is maintained and calibrated as per approved schedule and documented.

Qualification

• Coordinate qualification activities with QC and Production
• Compile, implement and perform the relevant qualification protocols as per SOP.
• Participate in change control assessments to ensure compliant status of affected equipment is not compromised.
• Ensure documents and procedures to operate and maintain equipment are in place.

Requalification

• Assess and recommend re qualification of equipment and utilities as appropriate as per Protocol.
• Prepare and perform re qualification of equipment and utilities as per SOP.

Governance, Risk and Compliance

• Review accuracy and integrity of protocols, reports and documentation generated comply with regulation.
• Review compliance of validation documentation with QMS
• Generate validation reports on a weekly/ monthly basis.
• Monitor implementation and correct own and/or team compliance with legislation, policies, and procedures.
• Participate in internal and external audits.

Skills Required

Background/experience

• Certification/ Diploma and a minimum of 5 years of related experience
• Supervisory/ Management experience
• Experience in validation techniques and computer related systems qualification

Specific job skills

• Comprehensive knowledge in the application of Qualification and Validation principles
• Knowledge of control and instrumentation systems, electrical systems and reading of electrical diagrams
• Understanding of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes, and objectives.

Competencies

• Interpreting and internalizing information
• Planning and organizing
• Meeting deadlines
• Taking action
• Working in teams

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JOB REQUIREMENTS:       

• Minimum Education Qualification – Matric/Grade 12.
• Must be computer literate, MS Windows, i.e., Word, Excel, Outlook, PowerPoint, etc.
• Experience in a stores/warehouse environment would be an advantage.
• Good communication skills, both verbal and written.
• Valid forklift driver’s license or have the ability to be trained as a forklift driver.
• Ability to plan and work logically and systematically.

BASIC JOB FUNCTIONS (Brief Summary)     

• Ensure that all raw materials are issued accurately and timeously to Production with strict adherence to cGMP protocols and principles and elimination of lost time.
• Perform Forklift duties as and when required.
• Accurately capture all data on the SAP system
• Assist with inventory controls and stock counts.
• Systematic filing of relevant documentation
• Maintaining the cleanliness of the raw materials store decanting facility, flammable store, off-loading bay, gas storage area
• Delivery of sundry items to various departments
• Other ad-hoc duties as required (all store-related duties within his scope)
• Complete all records and reports timeously and accurately as described in the relevant SOPs, protocols, and associated documentation.
• Comply with GMP requirements as outlined by Company SOP’s and written instructions in all tasks and activities.
• Ensure that products are stored according to the required SOP’s and documentation.
• Ensure all sections within the department maintain compliance with company GMP standards.

PERSONAL ATTRIBUTES (Brief Summary):   

• Ability to work independently as well as in a team.
• Highly motivated with a good work ethic.
• Willing to work overtime and possibly shifts as and when required.
• Attention to detail and accuracy.
• Good communication (written and verbal) with good data-capturing skills.
• Must be of sober habits and good attendance record.
• Interpersonal skills and customer relations. 

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Description

• To support the compilation and review of quality and regulatory documentation for regulatory submissions.
• Ensure the effective quality and regulatory change management for products manufactured by facilities contracted by Aspen SA Operations.

Requirements

Regulatory Compliance

• Regulatory affairs evaluation and approval of Change Requests for relevant Aspen SA manufacturing and CMO sites.
• Compile data packs for new product introduction projects or variations that are compiled for Aspen manufacturing sites or CMOs.
• Define implementation timelines for post registration variations for Aspen SA Operations and CMO products to ensure variations are submitted in accordance with business requirements.
• Provide regulatory intelligence and guidance on regulatory strategies for site projects.
• Ensure compliance with regulatory guideline requirements pertaining to product registrations and variations.
• Maintain and oversee the control of the product dossier IP where Aspen SA Operations is the MAH.

QS Management

• Preparing and adhering to relevant process flows and SOP’s regarding quality system responsibilities.
• Timeous management of records in the relevant Change Management Quality System,
• Review and approval of required master documentation from relevant change request
• Support any quality related processes in quality risk management, documentation management, or master data requests for Aspen SA Operations
• Drive continuous improvement projects to improve efficiency and compliance within Aspen SA Operations.

Sub-contractor Change Management

• Quality and Regulatory evaluation of Change requests for manufacturers/ distributors contracted by Aspen SA Operations
• Advising and follow up on execution of supporting data required to ensure regulatory and quality compliance for change requests.
• Ensure that CMOs comply with the latest regulatory GMP and product registration requirements.

Skills Required

Background/experience

• Matric/ Grade 12
• BPharm Degree (Baccalareus Pharmacia)
• 2-3 years of experience in Pharmaceutical Manufacturing and/ or Quality Assurance Environment
• Sound knowledge of Good Manufacturing and Good Documentation Practices
• Knowledge of Regulatory Affairs and product dossiers
• Computer literate

Specific job skills

• Strong working knowledge of pharmaceutical manufacturing
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives.
• Ability to liaise with different people and build relationships.

Competencies

• Offering Insights
• Taking Action
• Investigating Possibilities
• Communication skills

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Description

Perform QC and stability tests on raw materials, in-process and finished products, components & water to ensure quality and compliance. Review compliance of products to GMP, quality standards and product specifications. Provide services according to Production plan.

Requirements

Background/experience

• National Diploma in Analytical Chemistry with 2+ years' experience
• Laboratory experience

Specific job skills

• Advanced understanding of pharmaceutical testing methods
• Understanding of pharmaceutical manufacturing and corrective action programs
• Knowledge of Millennium Software (HPLC) and GC Software
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

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

Responsibilities

• Planning and Operational Support
• Optimise and facilitate implementation of current processes
• Propose changes or improvements to processes, tools and techniques

Test Preparation

• Prepare and analyse samples according to SOPs
• Prepare and operate laboratory equipment according to SOPs
• Perform calibration checks on equipment according to calibration procedure, to ensure accurate results
• Prepare reagents and solutions for testing
• Maintain good housekeeping

Testing

• Perform HPLC/GC analysis using MOA
• Perform routine analysis on in-process and final products, raw materials and components
• Perform routine stability tests such as related substances, assay and dissolution to assess quality of product
• Perform daily and weekly water testing according to SOP
• Support testing for OOS investigations to establish any systematic issues in process or testing
• Handle problems efficiently according to quality policy
• Report feedback on services or outputs regularly to customers
• Check HPLC/GC runs regularly during the shift
• Provide internal customers with accurate HPLC/GC results
• Propose, develop and update methods for improving customer service
• Check, document and report operational output against actuals
• Communicate deviations for production and process improvements
• Utilise technology as per qualification requirements

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
• Record, interpret and report testing results to management, including OOS results

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Description

• Assist in the testing of all drugs and materials.

Requirements

Sample testing before storage

• Coordinate the unpacking of the boxes to acquire the sample, as per the sampling plan for materials.
• Sample content according to required specifications.
• Check the repacking of the box for stocking (e.g., wrapping) according to directions.

Sending samples to lab

• Complete sampling sheets
• Send completed sampling sheets to Quality Control

Sample testing after storage

• Pick the material and request it be brought to the testing area.
• Sample content by required specifications.
• Check the repacking of the box restock.

Raw material dispensing

• Receive job orders in the system.
• Locate and pick the pallet.
• Place the job number on the pallet.
• Update the status of the job order into the BAAN system.
• Secure the load.
• Dispense the material.
• Move the load to the ready area or shipping area.

Planning & procedures

• Prioritise and execute responsibilities effectively for a single technical area.
• Prioritises daily work to complete tasks/ projects assigned by others.
• Work within established policies, practices, and guidelines, as well as established quality and safety checks
• Work is periodically reviewed by others for compliance, quality, and accuracy.

Asset/ Resource coordination

• Determine resource needs within own area of responsibility.
• Request required assets and resources for the fulfilment of work duties.
• Use assets and resources optimally within own area of responsibility.

Technical expertise

• Optimise own work processes.
• Identify gaps in current policies, procedures, and legislation as it relates to own area of work.
• Facilitate implementation of processes in own area of work

Reporting & record keeping

• Provide information for completion of reports.
• Maintain and update records and systems as required.

Skills Required

Background/experience

• 2-4 years’ Warehouse experience in Pharmacare
• Minimum of a National Certification (N4-N6)