Career Opportunities at Aspen Pharma Group

OBJECTIVE OF ROLE: 

• To continuously provide high quality digital support and training to the Aspen SA Commercial User community. 

KEY RESPONSIBILITIES

• Troubleshoot and support employees with hardware and software issues in person, remotely and via phone (computer / mobile device issues
• Timeous escalation of hardware and software issues through the right channels
• Provide guidance and support for office-based and remote users, including advising on and troubleshooting home office connectivity issues
• Work closely with the Project Management Office (PMO) and play an active role in the transition of IT-managed projects to the “live” environment
• Support new products deployed by the Application and SecOps teams
• Update the relevant service management systems
• Is responsible for their own upskilling through continuous learning, to ensure their knowledge of new platforms and systems always current
• Ensure that knowledge of new platforms and systems is proactively shared with end users
• Support virtual meetings (internal and external meetings) Provide guidance and support on Audio Visual systems and equipment
• Provide training and guidance to external presenters who may be unfamiliar with Aspen’s tools
• Assist in the creation and maintenance of online forms (Microsoft Forms) and SharePoint sites.
• Continuous improvement of digital support services (from the logging process through to resolution)
• Knowledge sharing back to the relevant IT teams of issues found that can be avoided / eliminated / managed centrally

Requirements

EDUCATIONAL REQUIREMENTS:

• Matric / Grade 12 Certificate
• Diploma or Certificate in the Information Technology field would be an advantage, with the ITIL qualification being ideal (or experience as listed below)

 EXPERIENCE REQUIRED:

• Minimum of three (3) years' experience in an Information Technology environment
• IT Service / Help Desk experience is advantageous
• Experience in Microsoft O365 Cloud is an advantage

SOFT SKILLS:

• Working knowledge of common information technologies and systems
• Communicating complex concepts to a general audience
• Troubleshooting common IT issues, utilizing a problem-solving mindset
• Excellent time management skills
• Ability to think Analytically
• Customer-centric orientation
• Excellent interpersonal & communication skills (verbal & written)
• Passion for upskilling, training and empowering others
• Outstanding ability to be a Team player

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Description

• Monitor manufacturing compliance to GMP and statutory requirements.
• Monitor adherence to guidelines, procedures, and document controls.
• Deliver expected productivity targets as per business requirements.
• Related administrative tasks.
• Serve as back up to Team Leader on shift.

Requirements

Planning and Procedures

• Plan and prioritize daily, weekly, and monthly activities
• Determine, request, and use resources/ assets optimally

Inspections and Verifications

• Verify schedule 5 products
• Verify certified clean status of rooms and equipment
• Verify, review, and approve verification of measuring equipment performance, calibrations, and sampling, and dispensing of materials

Line & Production processing

• Perform, review, and approve line sign-on’s, closures and clearance authorization's.
• Perform, review, and approve batch reconciliations to product specifications and quality.
• Ensure production process adherence to standards and specifications.

Process and system improvements

• Manage, review, and approve change control programs and deviations / concessions comply to standards and specifications
• Manage and resolve customer complaints
• Optimize processes and identify gaps in policies / procedures
• Drive CAPA investigations in area of focus

Compliance & Auditing

• Perform and review shift GMP checks, environmental checks, and agent expiry dates, and ensure continued compliance
• Verify good document practice as per SOP and regulation
• Verify the identity of bulk product and printed packaging materials, and conduct intermix checks to assess uniformity
• Verify IPCs are in line with product quality and specifications
• Review and approve preliminary batch records
• Audit logbooks and systems

Troubleshooting

• Investigate deviations and concessions, and assess risk
• Raise deviations and implement corrective action
• Raise maintenance notifications as and when required
• Training and technical expertise
• Train new Pharmacists and PMAs on SOPs in transition period
• Identify refresher or awareness training needs

Administration & Record keeping

• Complete batch records and labels
• Complete deviation forms as required
• Query documents and sign off declarations
• Perform and verify calculations in BMR
• Maintain and update records and systems as required
• Retrieve supporting documentation and records to facilitate and support query resolution

Skills Required

Background/experience

• Minimum of Bachelor's degree preferred, ideally in pharmacy
• 1- 3 years’ related work experience
• Pharmaceutical manufacturing experience
• Registration with Pharmacy Council

Specific job skills

• Comprehensive knowledge of pharmaceutical manufacturing, standards, and compliance requirements
• Ability to interpret and implement policies, processes, and objectives

Competencies

• Information gathering
• Interrogating information
• Meeting deadlines
• Finalizing output
• Taking action

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Description

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

Requirements

Planning and Operational Support

• Optimize and facilitate implementation of current processes.
• Propose changes or improvements to processes, tools, and techniques.

Test Preparation

• Prepare and analyze 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.
• Utilize 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.

Skills Required

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

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Description

• Perform sampling, labelling and inspection of material.
• Perform routine testing.
• Maintain good housekeeping.

Requirements

Planning and Operational Support

• Act as a technical/ subject matter resource.
• Facilitate implementation of current processes.
• Identify gaps in current policies and procedures.
• Provide input into changes or improvements to processes, tools, and techniques.

Test Preparation

• Handle materials in sampling areas according to SOPs
• Maintain good housekeeping in sampling areas
• Prepare reagents and solutions when required
• Prepare lab according to SOPs
• Prepare and maintain equipment, PPE, and facilities
• Sample materials for testing according to SOPs and sampling plans
• Analyse samples to ensure compliance with specification
• Report any non-conformances/ compromised samples
• Document released test samples for customer consumption
• Label and release sampling material according to SOPs

QC Lab Testing

• Perform routine testing on equipment according to SOPs

Stability Testing

• Perform routine stability tests according to SOPs

Water Testing

• Perform daily and weekly water testing according to SOPs

Package Testing

• Perform routine package testing according to SOPs
• Examine labelling/ artwork and identify mislabeling / breaches, report discrepancies

Reporting and Record-Keeping

• Document and file data according to SOPs and regulation
• Update records and systems as required
• Record and report results; OOSs to be reported to supervisor

Skills required

Background/experience

• Grade 12 with Mathematics and preferably Physical Science or Biological Sciences
• 1-3 years laboratory experience

Specific job skills

• Comprehensive understanding of pharmaceutical testing methods, laboratory processes and procedures
• Good Laboratory Practice
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes, and objectives

Competencies

• Information Gathering
• Interrogating Information
• Maintaining Accuracy
• Following Procedures

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Description

• 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.

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

Skills Required

Background/experience

• National Certification (N4) or 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

Competencies

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