Job vacancies at Aspen Pharma Group

JOB PURPOSE

To manage the integration of technical projects across the Aspen Group with high focus on sterile products.

Apply expert functional knowledge and experience with sterile products, to provide optimal project delivery

Responsible for taking cost saving, supply sustainability, technical transfer and regulator initiated projects and converting them into relevant product supply, through designing, problem solving and executing technically sound delivery solutions

Overseeing and managing all aspects of project scope, timelines, cost, resolving technical related issues ensuring successful product transfer.

KEY PERFORMANCE AREAS

Manage the technical transfer process, according to the relevant department procedures and SOPs, from initiation to completion

• Facilitate processes which include feasibility, planning scoping and initiation of new projects
• Manage delivery of site technical project plans and generate overall timeline from project initiation to first supply for review by sponsors and stakeholders
• Design and fix processing of products to improve the product quality

Management of overall project costs and budget

• Direct site for technically challenging issues and generating business case models to implement new or enhance existing processes.
• Management of technical service providers, challenging the costs and benchmarking quotes.
• Manage project budget through the Project Budget Management Process, including decisions on approval of forecasted expenditure and assessing impact of scope and timeline changes on yearly and overall Project Budget

Collaborate& communicate with all stakeholders to ensure successful implementation of Project Metrics

• Manage Project and technical meetings including Kick off, close out, weekly progress and ad hoc technical meetings with Ownership of agendas, minutes & action item repository
• Provide monthly status updates for projects to facilitate the monthly dashboard reporting, quarterly Board reports and risk registers
• Assist Group or site procurement by providing information required to source quotes for components / raw materials or alternate material sources
• Manage technical queries/issues between sending and receiving sites and act as Product SME when in house expertise is not available
• Troubleshoot process problems, Support sites with Root cause investigations, writing of reports and closing CAPA’s
• Manage project risks and escalate significant changes in timelines to manager
• General project communications keeping stakeholders informed and directing daily workflow across sites
• Provide Technical inputs into Site and Project Portfolio Steercom meetings

Provide support to Regulatory teams to ensure submission timelines, Requests For Information (RFI’s) and technical related queries are actioned within the stipulatedtimelines

• Manage technical queries from supply and Regulatory hubs and support strategies concerning submission. Provide review of compiled dossier sections
• Manage responses and closure of RFI’s from regulators by directing and coordinating site responses and authoring justifications where relevant.

Deliver Group KPI’s though successful completion of critical milestones associated with project plans and meeting scheduled implementation dates within defined budget

• Apply expert functional knowledge and experience to provide optimal project delivery
• Risk mitigations to prevent impacts on timeline and cost

Sterile Subject Matter Expert (SME)

• Aseptic and terminal sterilized products, (solutions, emulsions, lyophilized products,
• Primary packaging components (Vials, ampoules, stoppers, caps, PFS, Blow fill seal products, Single dose & Multi-dose)
• Filters & Filter validations,
• Autoclave cycles;
• Single use technology;
• Extractible and leachable studies /  Antimicrobial effectiveness testing / Elemental impurities / Delamination studies
• Visual inspection & leak detection;
• Provide internal training on key aspects related to sterile products pharmaceutical manufacturing
• Guiding and Mentoring of the junior members of the projects team

Ad Hoc / Specific Activities

• Keep abreast of latest technical developments and GMP requirements
• Provide Support / assistance to other Project managers in the Group Operations Technical projects and Group Operations Projects Team as and when required

Requirements

JOB REQUIREMENTS

EDUCATIONAL QUALIFICATIONS & EXPERIENCE

• Degree in Science, Process Engineering or Biochemical Engineering
• University qualification 
• 5 - 10 years’ experience in the pharmaceutical, biological or biochemical environment dealing with sterile product processing

SPECIFIC EXPERIENCE, KNOWLEDGE AND REGISTRATIONS 

• 5 years relevant project management experience
  • Working knowledge of pharmaceutical standards/ compliance
  • High technical expertise in sterile products: process, sterilisation, materials and primary packing components

WORK-SPECIFIC SKILLS & EXPOSURE

• Pharmaceutical industry work experience in a manufacturing facility
• Pharmaceutical  supply chain, regulatory, laboratory and Quality knowledge preferable
• Core knowledge of pharmaceutical manufacturing, GMP and Quality (Deviation classification and justification) and technical transfer (ISPE)
• Report writing
• Budget management
• Sound Knowledge of IT, excel, word, MS projects, Power point, Dashboards

SKILLS AND ATTRIBUTES

• Ability to work in an international and dynamic environment
• Planning & Organising
• Accuracy & attention to detail
• Disciplined and focused
• Effective Time Management
• Problem solving & Decision making
• Information seeking & sense of urgency
• Analytical & Analysing skills
• Interpersonal skills
• Clear & Effective communication skills (Internal & External)
• Translate and direct project strategy, make decisions based on sound principle
• Assertive
• Initiative
• High level of integrity, ethical values & confidentiality
• Self-motivated, Performance driven & efficient
• Flexibility to work outside standard office hours (time zones)
• Flexibility to travel locally & Internationally as required
• Budget skills / knowledge

KNOWLEDGE

• Financial Principles
• Principles governing regulatory and quality requirements such as GMP, ICH, SUPAC guidelines on stability, validation of processes, equipment classification
• Regulatory market requirements – USFDA, EU, TGA, WHO, SAAPRA, ANVISA, NMPA (China)
• Pharmaceutical & Technical Industry Knowledge
• Project Management basics and tools

ASPEN COMPETENCIES 

Business

• Multi-tasking
• Focused
• Leadership
• Teamwork

People

• Embraces change
• Capacity for & Resistance to stress
• Meeting facilitation

Self

• Contributes special expertise
• High Standards
• Personal responsibility
• Self-assurance

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Description

Overview

• Monitor and report on manufacturing compliance to GMP and statutory requirements
• Ensure adherence to guidelines, procedures, document controls and support with related administrative task

Requirements

Responsibilities

Inspections and Verifications

• Perform visual inspections of rooms, machine parts and equipment
• Verify that rooms and equipment are certified clean as per SOP
• Verify scale and measuring equipment performance and daily calibration as per SOPs, protocols and schedules
• Verify daily sampling, dispensing of materials and its mass/ volume
• Perform housekeeping of rooms and equipment

 Line & Production processing

• Perform line sign-on and closure
• Check and authorise packaging line clearance
• Order and maintain substance materials
• Perform batch reconciliations to product specifications and quality
• Monitor production process in line with standards and specifications

Process and system improvements

• Manage change control programs and deviations/ concessions in line with SOPs, standards and product quality and specifications
• Manage and resolve customer complaints
• Optimise processes and identify gaps in policies/ procedures

Compliance & Auditing

• Conduct shift GMP checks and ensure continued compliance
• Conduct environmental checks and check expiry dates of agents
• 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
• Check 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 PMAs on SOPs
• 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

Skills Required

 Background/experience

• Post Basic Registration with the Pharmacy Council
• 1-3 years’ related experience in manufacturing 
• Pharmaceutical manufacturing and/ or Pharmacist Assistant experience 

Specific job skills

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

Competencies

• Interrogating information
• Meeting deadline
• Finalising outputs
• Maintaining accuracy

 Competencies

• Interrogating information
• Meeting deadline
• Finalising outputs
• Maintaining accuracy

 Accountability and Decision Rights

• Timely and accurate performance of responsibilities for a single technical area or group of closely related tasks, under supervision
•  Learn and implement policies, procedures, quality and compliance standards
•  Recognise and resolve basic, routine or common/ repetitive problems
• Seek assistance on complex issues and referring non-prescribed matters
•  Stay up to date on legislation and industry regulations  

Decisions relating to

•  Own work, within limited, defined parameters
•  Prioritisation of basic tasks, with clear guidance