New Vacancies at Aspen Pharma Group

Requirements

Operational Support

• Identify gaps in current policies and procedures.
• Optimize and facilitate implementation of processes.
• Operate equipment as per standards and expected efficiency and ensure compliance to GMP and SHE standards.

Inspections & Verifications

• Perform pre-production checks such as environmental, scale and equipment pre-checks as per BMR, SOP and product specifications.
• Verify scale and measuring equipment performance.

Production Preparation

• Ensure availability of materials and equipment for manufacturing
• Perform Type-A and Type B changeovers; Clean and prepare the area and equipment before and after processing.
• Prepare solutions for production activities as per SOP.

Production Processing

• Clear and feed the manufacturing line.
• End of line packing and inspections
• Perform central lining review to establish optimal production settings.

Routine Support Tasks

• Clean area and equipment before and after processing of materials
• Perform equipment pre-checks and facilitate transfer of equipment.
• Sort defected product and dispose of according to procedures.
• Provide information to assist with campaign preparation.
• Train new Assistants and Operators and transfer of skills
• Operate manufacturing and packaging lines as per requirements.
• Resolve minor - and assist with major breakdowns/ maintenance.
• Perform change overs, settings, and minor maintenance as per autonomous maintenance standards.

Troubleshooting

• Conduct root cause problem analysis on machines.
• Raise maintenance issues with management for resolution.
• Perform adjustments and preventative maintenance on machines.

Reporting & Record Keeping

• Complete batch record labels and OEE sheets
• Perform half-hourly inspections of production area(s)
• Record manufacturing/ machine down time.
• Attend shift meetings.
• Perform IPQC or quality inspections per responsible areas.
• Provide information for reports; consolidate standard documents.
• Maintain and update records and systems as required.

Skills Required

• Background/experience
• National Certification (N4) / Matric 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

go to method of application »

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, QlikSense 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

 Knowledge:

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

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 sales environment

go to method of application »

Requirements

Operational Support

• Execute production activities within established policies, practices, and guidelines, as well as established quality and safety standards.
• Optimize 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/ minimize 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.

Background/experience

• National Certification (N4) / Matric with 0-2 years’ related experience
• Manufacturing experience would be an advantage.

Specific job skills

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

go to method of application »

MAIN DUTIES:

• Attend to Marketing Code Compliance via the (REP ASSIST) monitoring system for planned events:
• Meetings, sponsorships, promotional items, competitions, grants, DSP, webinars, congresses, stands, digital marketing, influencers, social media campaigns, etc
• Apply all regulations and rules for approval
• Claims process
• Promotional material has been approved on Veeva for the specific event
• Invites; agendas; stand builds; advertising; webinar platforms; slide decks approved and attached
• All costs indicated
• Speaker agreements are in written format and signed before event takes place
• All transfer of Value indicated – travel, accommodation, and any hospitality
• Check for legal notices, use of correct templates
• Disclaimer slides loaded as part of the talk
• Disclosures of affiliation, conflict of interest declared, CDA signed
• All costs have been clearly identified and invoices attached
• No entertainment loaded and shown on programme
• Venue and hospitality are appropriate to the occasion and aligned with all requirements
• Attendance registers signed and uploaded after the event aligned with POPIA
• Is it the right audience for the event – what is the rationale
• Speaker choice indicated with rational for FMV calculation
• Have CPD accreditation been applied for, certificates sent after the event for HCP attendees
• All data and attachments correspond to event loaded on Rep Assist
• All costs tying up with invoices submitted.
• HCP request for CPD and sponsorships included
• Record keeping for minimum 5 years 
• Rep Assist System
• Reporting issues with Rep Assist to IT and developers when needed. 
• Arrange with IT and developers for System updates/changes/maintenance in line with code or when ways of working is updated.
• Loading new sales and marketing employees
• Updating data as and when changes are required
• Assisting users with advice on the program in line with the code 
• Give direction and assistance to the Sales,  Marketing and Medical teams with respect to interpreting, implementing, and applying rules and regulations to meet the quality requirements of the Medicines and Related Substances Act, 101 of 1965 as amended, The South African Code of Marketing Practice for Health Products Code and Guideline, the Aspen Group Code of Marketing Practice, Third-Party Alliance Partner Marketing Code requirements,  and various other acts and guidelines applicable.
• Representing Aspen as CCCO within the Pharmaceutical industry as it relates to the Marketing Code Authority and Group Code.
• Training of staff on applicable SOPs, Rep Assist system, Expense process, Marketing Code/s to ensure we all follow Ethical marketing practices.
• Ensure and maintain MCA code certification for all Sales and Marketing staff
• Compliance contact and responsibility for Third Party Alliance Partners:
• Assist with various requests from 3rd parties on compliance including audits and contracts
• Compliance monitoring and reporting
• Audits
• Marketing Code Compliance – internal (annual) and external (bi-annual)
• Self-inspection audits quarterly, follow up on outstanding documents
• Address issues/findings with greater team
• Trackers kept up to date
• Attendance records kept current
• Alerts for MCA exams and follow up 100% compliant 
• Complaint handling
• Investigation process
• Compilation of letter to Third-Party with Legal assistance
• Obtain Legal and RA reviews of letter
• Company to Company process followed for self-regulation
• Followed through until completion
• Keep record of event on file for auditing and tracking 
• MCA website maintenance
• Loading and updating profiles
• Maintenance of database
• Setting exams for users
• Password reset / logon emails
• Downloading reports and act as required
• Reminders sent to users to renew MCA certifications
• Helping users to navigate the website
• Reporting errors to MCA found on website
• Maintenance of unit licenses to ensure we have enough units to cover examination requirements 
• Reporting
• Quarterly report on Government interaction to Management and Third-Party Alliance Partner
• Quarterly reports for Third-Party Alliance Partners
• Monthly report to Line Manager; Responsible Pharmacist and AGI
• RSM and Manager reports as required
• Monthly MCA report for license renewals
• Monthly Rep Assist database report for integrity and check on profile changes
• Yearly report on Marketing Code declarations 
• VEEVA VAULT - Aspen Promomats
• Checking and approval of promotional and non-promotional material /items applying Code and Regulations for approved usage and distribution

Qualifications

• Matric / Grade 12
• Bachelor of Pharmacy degree or equivalent

Minimum Requirements

• Registered with the South African Pharmacy Council as a practicing Pharmacist
• 5 years’ experience in the Pharmaceutical industry in a Code Compliance or similar Regulatory Affairs or Medical / Compliance role
• Working knowledge of the Marketing Code
• Advanced Knowledge of the legislation applicable to the Pharmaceutical Industry in South Africa (including but not limited to the Medicines and Related Substances Act 101 of 1965)
• Advanced knowledge of SAHPRA requirements and guidelines
• Advanced computer literacy on Microsoft Windows applications (including Word, PowerPoint, Outlook and Excel)

Preferred Requirements

• Intimate Knowledge and Experience in Marketing Code Authority Compliance Code in South Africa
• Technical qualification related to the Pharmaceutical industry is a bonus

go to method of application »

Requirements

Planning and Operational Support

• Optimise and facilitate implementation of current processes.
• Identify gaps in current policies and procedures.
• Propose changes or improvements to processes, tools, and techniques.

Microbiological Testing

• Perform microbiological tests on raw materials, in process and final products to ensure quality and compliance with GMP standards.
• Test water according to SOPs and testing schedule.
• Notify Production of source of any contamination timeously.
• Develop and implement plans to control level and source of contamination.

Environmental Management

• Perform sampling and testing of external environment, according to SOPs and sampling plan / schedule.

Quality Control

• Report OOS results and deviations immediately.
• Manage frequency of testing and sampling to maintain a quality process.
• Maintain good housekeeping.
• Manage and coordinate the use, maintenance, and calibration of testing equipment according to SOPs.
• Ensure continuous compliance of laboratory with GMP standards.

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 

Background/experience

• National Diploma in Microbiology with 6+ years’ experience
• Microbiological laboratory experience

Specific job skills

• Advanced knowledge of microbiological testing methods
• Understanding of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes, and objectives.