Job Openings at Aspen Pharma Group

OBJECTIVE:
Lead supplier development, supplier negotiations, RFQs, and CMO category strategy for major suppliers. Identification of continuous improvement opportunities

KEY RESPONSIBILITIES
Supplier management

• Communicate and negotiate with suppliers
• Monitor quality standards and identify performance failures
• Conduct supplier audits and report on supplier performance
• Manage supplier communications and documents and process flow, including RFIs, RFP, RFQ, and RFB’s
• Resolve supplier issues; maintain working relationships with key suppliers
• Set up new vendors and coordinate with legal to support new contracts; maintain/ update existing contracts
• Identify new suppliers and products in the marketplace
• Vet potential suppliers’ capabilities (delivery, quality, services)
• Review insourcing and outsourcing opportunities
• Negotiate with suppliers to carry stock for fast moving items
• Assist in the drafting of specifications as required, and provide advice and guidance to customers on procurement processes
• Review and approve price variances (Order vs Invoice Prices)
• BBBEE and procurement administration

Risk management

• Maintain and report on adherence to internal and external compliance requirements
• Actively reduce third-party risk exposure
• Carry out risk management processes within CMO category

Quality and qualifying products

• Assist quality teams to obtain products needed to conduct finished product testing
• Schedule product trials and coordinate samples

Reporting and record keeping

• Maintain repository of procurement-related knowledge
• Maintain complete, compliant documentation of purchasing activities

Maintain standards and update SOPs for documentation and filing requirements

• Budgeting
• Manage and optimise use of Category budget
• Provide input into required changes in resources to enable achievement of objectives
• Monitor, track and report on expenditure against budget

Planning and coordination

• Optimise processes, identify gaps in policies, procedures and legislation, and propose changes or improvements to management
• Provide technical advice to internal stakeholders

Accountability & Decision Rights

• Provide updates to management on work progress/ quality
• Serve as a technical advisor to management to resolve the most complex technical challenges, and handle escalated issues as a lead technical expert
• Escalate out-of-policy matters
• Independent decisions relating to:
• Correction/ containment of errors of significant impact
• Prioritisation of tasks and responsibilities within overall direction and clearly defined parameters/ schedules and established policies, practices, guidelines, and quality and safety checks

Requirements
SKILLS AND KNOWLEDGE

• Computer literate – MS Office

Competencies

• Customer Awareness
• Meeting Deadlines
• Making Decisions
• Planning and Organising
• Interrogating Information
• Innovation, Creativity and Problem solving
• Demonstrate initiative, creativity, outstanding problem-solving skills, and reliability
• Work requires problem resolution to non-standard and unique technical, operational, and business challenges
• Work with team to resolve more complex tasks and day-to-day technical/ procedural challenges.
• Often handle escalated issues
• Regularly serve as a technical advisor to management to resolve the most complex technical challenges.
• Regularly lead others in identifying original and resourceful approaches to challenging and unusual work situations
• Independently resolve highly complex service/support problems, escalating out-of-policy matters

EDUCATION & EXPERIENCE

• Matric
• 6 years' relevant experience
• Experience in a manufacturing procurement environment, and preferably with significant experience in a CMO environment
• National Diploma in relevant field (Procurement, Logistics, Supply Chain Management, Finance), or a related

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OBJECTIVE:

Schedule, order, expedite, receipt and manage the material bulk and finished packs in accordance with demand

KEY RESPONSIBILITIES

Demand Planning

• Review and verify demand forecast downloaded in ERP system.
• Review Inventory level projection file (ILP) and RO list. 

Supply Planning

• Monthly sales and operation process.
• Reschedule backlogs daily, and prioritise and expedite as needed.
• Long term planning (6months +). Identifying capacity constraints.
• Firming of orders on ERP as per demand forecast, obtain authorization as per the approvals framework and distribute to suppliers.
• Regular follow up with suppliers on open order status.
• Demand Forecasts verified and shared with suppliers.
• Manage all supply related activities for site changes. 

Reporting and performance management

• Stock-out reports – Perform stock out analysis.
• Vendor Performance Management - compile quarterly reports
• OTIF reports – maintenance and distribution
• Compile and update monthly and quarterly sales forecast reports.
• Maintain tracker for non-conforming stock investigations and claims.
• Maintain obsolescent stock report.
• Report on budgeted, planned and actuals sales.

Logistics Planning

• Plan shipments on weekly basis based on sales plan to achieve OTIF
• Liaise with manufacturing sites, logistics service providers to ensure documentation is available and is processed with shipments
• Track shipments including raw material shipments (Toll)
• Identify any risks to delivery of our orders
• Coordinate actions emanating from the projects meetings

Planning & procedures

• Oversee work / serve as a lead technical expert in a complex area/project 

Asset/ Resource coordination

• Provide input into required changes in resources to enable achievement of own objectives
• Determine resource needs of own area of work; request and allocate required assets and resources for the fulfilment of work objectives 

Technical expertise

• Optimise current processes; identify gaps in current policies / procedures
• Propose changes or improvements to management on processes, tools, techniques, and products
• Provide technical advice for issues experienced by internal stakeholders

Accountability & Decision Rights

• Apply advanced and mastered knowledge of concepts, methods, terminology, codes, quality standards and specialised job requirements
• Provide updates to management regarding team or operational performance, work progress and quality
• Serve as a technical advisor to management to resolve the most complex technical challenges, and handling escalated issues as a lead technical expert
• Escalate out-of-policy matters

Independent decisions relating to:

• Non-routine issues
• Correction and/ or containment of errors of significant impact (financial loss, customer business, materials and/ or equipment downtime)
• Prioritisation of tasks and responsibilities within overall direction and clearly defined parameters/ schedules and established policies, practices, guidelines, and quality and safety checks

Requirements
SKILLS AND KNOWLEDGE

• Computer literate – MS Office
• Production planning
• Sound understanding and knowledge of MRP/ MPS logic

Competencies

• Interrogating Information
• Making Decisions
• Planning and Organising
• Meeting Deadlines
• Customer Awareness

Innovation, Creativity and Problem solving

• Demonstrate initiative, creativity, outstanding problem-solving skills and reliability
• Work requires problem resolution to non-standard and unique technical, operational and business challenges
• Work with team to resolve more complex tasks and day-to-day technical/ procedural challenges. Often handles escalated issues
• Regularly serve as a technical advisor to management to resolve the most complex technical challenges. Regularly leads others in identifying original and resourceful approaches to challenging and unusual work situations
• Independently resolve highly complex service/ support problems, escalating out-of-policy matters

EDUCATION & EXPERIENCE

• Matric
• 6+ years' experience
• National Diploma in Logistics or Supply Chain Management 

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Description

• Perform validation exercises of production and lab equipment, utilities, packaging and processes to ensure specific standard of compliance is met

Requirements

Responsibilities

• 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

Validation

• Perform validation exercises in compliance with GMP standards and validation schedules
• Maintain compliant status of equipment and processes

 
Qualification

• Perform the relevant operational qualification protocols as per SOP to ensure new equipment/ utilities/ packaging function as per intended use
• Perform the relevant performance qualification protocols as per SOP to ensure new equipment/ utilities/ packaging function as intended over time and within limits
• Investigate and report OOE results, and perform re-tests
• Participate in change control assessments to ensure compliant status of affected equipment is not compromised
• Conduct routine inspections of equipment and utilities to identify any deficiencies and ensure quality standards are being adhered to
• 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

Reporting and Record-Keeping

• Compile, maintain and update validation documentation as per SOP and QMS
• Generate validation reports on a weekly/ monthly basis

Requirements
Background/experience

• National Certification (N4-N6) or Trade Tested Artisan with 2-4 years’ related experience
• degree or equivalent qualification in Science (Chemistry, Microbiology) or Engineering (Chemical, Pharmaceutical or Process), or equivalent industry experience
• Aseptic pharmaceutical manufacturing process and automated packing experience

Specific job skills

• Comprehensive knowledge in the application of Qualification and Validation principles pertaining to aseptically filled products
• Knowledge of control and instrumentation systems, electrical systems and reading of electrical diagrams
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Interrogating information
• Maintaining accuracy
• Following procedures
• Technical writing
• Accountability & Decision Rights
• Apply advanced competencies and skills, comprehensive knowledge of technical, quality and regulatory standards
• Independently resolve issues and complex matters
• Escalate highly complex matters

Independent decisions relating to:

• Prioritisation and execution of own responsibilities within established policies, practices and guidelines, as well as established quality and safety checks
• Correction and/ or containment of errors of significant impact

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Overview

• 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
Responsibilities

• Planning and Procedures
• Plan and prioritise 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 authorisations
• 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
• Optimise 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
• Bachelor’s degree 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

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Overview

• Operate equipment in the manufacturing and packing of products
• Prepare, clean, and inspect work areas and equipment
• Troubleshoot machines and raise maintenance issues
• Carry out required training and administrative tasks

Operational Support

• Identify gaps in current policies and procedures
• Optimise 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

ProductionPreparation

• 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

Background/experience

• National Certification (N3) 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