Active Jobs at Aspen Pharma Group

Description
Overview

• 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

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

Requirements
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 deadline
• Following Procedures
• Maintaining Accuracy
• Customer Awareness
   

go to method of application »

OBJECTIVE

• To support the SA Commercial Business to realize the commercial strategy and to achieve the annual targeted growth and revenue through successful new product introductions and maintenance of current product portfolio in the (South Africa OR South African Development Community (SADC) region), by ensuring successful Marketing Authorisation and variation approval from the (SAHPRA OR Regulatory Authorities of the member states) within the committed timeframe.  
• The role undertakes responsibility for compliance with the Regulatory for the New Product Launch Pipeline and the existing product portfolio in the region, through the successful completion of assigned activities according to the (South African OR SADC) Regulatory plan. 

KEY RESPONSIBILITIES

•  To provide regulatory and administrative support to optimise Regulatory processes and record-keeping.
• FINANCIAL
• Effective utilization of resources to keep processes cost effective.
• CUSTOMER
• Display a professional attitude when responding to customers.
• Propose, develop and update methods to improve customer services.
• Effective liaison and communication with internal and external customers, including but not limited to Regulatory Authorities, external consultants and agents, Quality Assurance, Project Managers, Artwork, New Product Launches, Manufacturing sites, Pharmacovigilance, Medical Information, AGI, APTL
• SYSTEMS, DATABASES AND TRACKERS 
• Initiate change controls and action items in the eQMS.
•  Track medicinal samples for registration submissions and development work.
• Identify, track, and manage free space available in safes.
• Track internal and off-site archiving.
• Enter SMF information onto relevant databases.
• Utilise systems, databases, and trackers to provide accurate information to internal and external customers on request.
• ADMINISTRATIVE
• Type, print, copy, scan and bind documents.
• Retrieve from and return IP to safes
• Create, label and archive files.
• Receive Local Document Archiving Forms. Allocate space for new files in the safes and update IP Database
• Ensure sufficient free space available in the safes, and if required, consulting with the line manager to identify which files can be archived off-site
• Request payments and provide proof of payment to the requestor
• Ensure delivery and/or collections to and from SAHPRA
• Arranging for drivers and maintain a delivery/collections log
• Ensure proof of receipt of SAHPRA submissions and correct filing
• Send parcels (documents, samples, CD’s etc.) and supportive documentation to Regulatory Authorities, agents and/or other Aspen departments via courier
• Assist in updates of SOP’s, working instructions, forms, templates as they relate to the administrative functions of the department
• Upload submission to SAHPRA via their Digital Variations Portal (DVP)
• Request import permit, export permit or import/export authorisation letters from SAHPRA.
• Provide training on administrative procedures to new/existing personnel 
• Maintain hard copy and electronic training matrix, training records and training files
• Arrange meetings, training, functions, venues, catering
• Manage meeting agendas and take minutes 
• Receive and collate monthly reports
• Receive, collate, and submit leave forms, overtime forms, expense claims, timesheets, invoices 
• Maintain and managing team lists e.g. birthdays, half days, working hours, employee numbers
• Assist with induction process for new employees
• Order stationery and stock the stationary cupboard
• Remove documents for shredding 
• OFF-SITE ARCHIVING
• Request retrieval of boxes from off-site 
• Track movement of products removed from boxes, and ensuring requestor signature
• Track on-site stock of boxes from off-site
• Ensure product information is returned, sealed and then returned off-site
• MEDICATION SAMPLES
• Monitor temperatures of both medication storerooms daily and record deviations
• Pack expired medicinal stock for destruction according to process and track accordingly
• Order, receive and track medicinal samples for investigational and registration purposes as required
• Notify relevant personnel of receipt of samples as per process
• SITE MASTER FILES
• Submit Site Master Files (SMFs) to SAHPRA
• Record SMF information on relevant network drive/systems
• Liaise with SAHPRA on the allocation of an SMF number
• Send notification of submission/receipt of SMF numbers to the relevant personnel as per process
• REGULATORY SUPPORT
• Supersede dossiers for specific regulatory activities as per departmental working instruction
• Ensure relevant history/status documents are updated
• Source regulatory information from dossiers, under supervision
• Compile follow up letters/extension requests and submit to the Regulatory Authorities
• Send notification of submission to relevant stakeholders
• Ensure regulatory submissions are signed by a pharmacist
• GENERAL
• Maintaining electronic folder structure as per departmental procedures
• Comply with regulations, guidelines, policies, procedures, and work instructions
• Adhere to deadlines/due dates
• Provide feedback to pharmacist’s/line manager once tasks are completed
• Escalate possible risks, critical issues which could result in delayed submissions
• LEARNING AND GROWTH
• Training and development identified and planned with the line manager
• Training is implemented according to ongoing personal and team development plans
• Up-skilling and multi-skilling are coordinated in line with staff development.

Requirements
EDUCATIONAL REQUIREMENTS

• Matric/Grade 12
• Diploma in Life Sciences, Biomedical Sciences or equivalent

KNOWLEDGE & EXPERIENCE REQUIREMENTS

• Experience with administrative work (3 years preferred)
• Knowledge of Pharmaceutical industry/regulatory affairs

SOFT SKILLS REQUIREMENTS

• Multi-tasking
• Results oriented
• Systems thinking
• Planning and organisational skills
• Focused
• Cooperation
• Proactive
• Responsibility & Accountability
• Resilience
• Informal communications skills
• Active listening skills
• Presentation skills
• Flexibility and tolerance for ambiguity
• Transition management
• Capacity for resistance to stress
• Perseverance and tenacity
• Understands Aspen story
• Aspen knowledge
• Optimism
• Passion
• Curiosity/learning agility
• Self-awareness
• High standards
   

go to method of application »

Description
Overview

• Carry out tasks related to receiving, material preparation, stocking, picking, cycle counting, finished goods preparation and loading of product

Responsibilities

• Receipting
• Check delivery vehicle and pallets for damage and ensure compliance to GMP.
• Unpack the truck and sort by supplier and lot numbers.
• Check shipping manifest and weigh materials; move suspect material to holding place.
• Complete and verify the goods receipt document.
• Hand receipt documents over to Administrator to book into BAAN.
• Dust and pack by hand, and place on pallets, or by means of equipment.
• Apply quarantine labels and/or location label on the material.
• Hand over to the Administrator for printing
• Stocking
• Place pallet on the shelf as per location label or scan location to update BAAN.
• Replace the label after “For release” is approved, if applicable
• Place scheduled products into the Schedule Cages under supervision of Pharmacist
• Picking
• Receive instruction to pick, locate and pick the pallet.
• Place job number on the pallet and return completed picking instruction to Controller/Administrator
• Secure the load.
• Move it to the staging area for shipping.
• Quality Control
• Report any stock/or location variances.
• Report issues to the superior
• Do general housekeeping.
• Do general GMP and Health and Safety functions.
• Planning & procedures
• Prioritise daily work to complete tasks/ projects assigned by others.
• Work within established policies, practices, and guidelines, as well as established quality and safety checks.
• Asset / Resource Coordination
• Determine resource needs within own area of responsibility.
• Request required assets and resources for the fulfilment of work duties.
• Technical Expertise
• Optimise own work processes.
• Identify gaps in current policies, procedures, and legislation as it relates to own area of work.
• Execute 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.

Requirements

Skills Required

Background/experience

• 2 to 4 years’ Warehouse experience (preference in Pharmacare)
• Minimum of a National Certification (N4 N6)
• SAP experience advantageous

Specific job skills

• Trainable to operate specialized MHE.

Competencies

• Interrogating Information
• Meeting Deadlines
• Customer Awareness