Group Operations Sterile Technical Project Lead

3 days ago

Durban North, South Africa Aspen Pharma Group Full time

**Job Purpose**:
To manage the integration of technical projects across the Aspen Group with high focus on sterile products.
Responsible for taking cost saving, supply sustainability, technical transfer and regulator initiated projects and converting them into relevant product supply, through designing and executing project plans including multiple departments across multiple countries
Overseeing and managing all aspects of project scope, timelines, cost, resolving quality related issues and ultimately ensuring technical transfer success

**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 the process of sourcing, compiling, controlling and distributing relevant information from the sending site into the Donor site Data Pack (DSDP) and circulating to respective technical and regulatory teams
- Manage the formal documentation associated with the technical project process as per the SOP (PID; TPSD, RPSA; PVSA; CMR; TTP, PTF; etc.); track the approval of the documents
- Manage the CTD Data Pack process of compiling, controlling and distributing Tech site submission information to regulatory compliance teams
- Manage delivery of site technical project plans and generate overall timeline from project initiation to first supply for review by sponsors and stakeholders
- Handover the Technical project to IP owner quality team once tech activities have been successfully concluded with minimum of T6 stability data is available

**Management of overall project costs and budget**
- Direct site for technical feasibility assessment and generating quotations on project costs; share costs with finance / PMO teams to run Business case evaluations
- Management of the various service providers, challenging the costs, benchmarking quotes & ensuring billing on time.
- 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 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 stipulated timelines**
- 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**
- 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

**Qualifications and Experience**
- Degree in Pharmacy, Science or Engineering
- Formal Project Mana

  • Group Operations Technical Project Manager

    2 weeks ago

    Durban North, South Africa Aspen Pharma Group Full time

    **ROLE PURPOSE**: To manage the end to end integration of technical projects across the Aspen Group. Responsible for taking cost saving, supply sustainability, technical transfer and regulator initiated projects and converting them into relevant product supply, through designing and executing project plans including multiple departments across multiple...

  • Group Manager: Solution Architecture

    4 months ago

    Durban North, South Africa Aspen Pharma Group Full time

    **COMPANY DESCRIPTION** We are a global specialty and branded pharmaceutical company, improving the health of patients across the world through our high quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversi?ed by geography, product and manufacturing capability. Aspen is a dynamic organisation built on...

  • Technical Project Manager Level 2

    5 months ago

    Durban, South Africa Games Global Operations Limited Full time

    Overview: Aurum is looking for a Project Manager who enjoys taking ownership, has a keen eye for detail, loves to solve problems, is process oriented, and has a hunger for constant improvement. Project responsibilities will include successful planning, managing workflows, implementation, follow ups, end-to-end delivery on medium to high complexity projects,...

  • Gdt Service Domain Lead Supply Chain Solutions

    9 months ago

    Durban North, South Africa Aspen Pharma Group Full time

    **JOB PROFILE** To lead the implementation of enhancements and continuous improvement initiatives that enables the development of system solutions to drive Supply Chain efficiency and value creation. To bridge the business requirements with the correct systems solution. To understand the business challenges and be accountable and responsible for developing,...

  • Technical Projects Manager Level 2

    7 months ago

    Durban, South Africa Games Global Operations Limited Full time

    Overview: The TPM2 is responsible for the end-to-end delivery of medium to large sized, medium to high complexity projects which including technical support **Responsibilities**: Technical Outputs: - Operationalize (Pre-Go Live, Go Live and Post Go Live)" Responsible for execution and communication of Deployment Plan (Pre-Go live, Go Live and Post Go...

  • Technical Project Manager Level 1

    3 months ago

    Durban, South Africa Games Global Operations Limited Full time

    Overview: Welcome to the Games Global world. We’re changing the rules of the game. Providing 1,300+ exclusive games from some seriously talented studios and not to mention a record-breaking progressive jackpot network, we help operators level up and create their perfect lobby. We are on the lookout for a Technical Project Manager Level 1 to join one of...

  • Financial Analyst

    2 months ago

    Durban, KwaZulu-Natal, South Africa Group Technical Security Management Full time

    We are seeking a highly skilled Financial Analyst to join Group Technical Security Management.Job SummaryThe successful candidate will be responsible for invoicing, project costings, supplier reconciliations, cashbook processing, and assisting with monthly management accounts.Key Responsibilities:Invoicing and project costings: Prepare accurate and timely...

  • Group Manager: Regulatory and Quality Management

    4 months ago

    Durban North, South Africa Aspen Pharma Group Full time

    Leads the development of regulatory and quality management system architectures in specific business, infrastructure or functional areas. Ensures that appropriate tools and methods are available, understood and employed in architecture development. - Within a change programme, leads the preparation of technical plans and, in liaison with business assurance...

  • Group Procurement Strategic Manager

    2 weeks ago

    Durban North, South Africa Aspen Pharma Group Full time

    **ROLE PURPOSE**: To support and manage activities as directed by the Procurement Head (in India) to develop sustainable, robust and cost-efficient procurement processes whilst implementing cost savings initiatives contributing to an effective supply chain. **KEY PERFORMANCE AREAS**: **Supplier Relationship Management** - Manage and implement the...

  • Group Digital Technology Service Domain Lead

    6 days ago

    Durban North, South Africa Aspen Pharma Group Full time

    JOB PURPOSE: Tactical role in the digital technology organisation and is accountable for the processing and coordination of appropriate and timely responses to incident reports, including channelling requests for help to appropriate functions for resolution, monitoring resolution activity, and keeping clients appraised of progress towards service...

  • Group Manager: Enterprise Resource Planning

    4 months ago

    Durban North, South Africa Aspen Pharma Group Full time

    Leads the development of ERP architectures in specific business, infrastructure or functional areas. - Ensures that appropriate tools and methods are available, understood and employed in architecture development. - Within a change programme, leads the preparation of technical plans and, in liaison with business assurance and project staff, ensures that...

  • Group Executive: Digital Technology

    4 months ago

    Durban North, South Africa Aspen Pharma Group Full time

    Develop and lead the Group’s digital technology strategy, aligning technology deployment with business objectives to ensure competitive advantage. - Lead Aspen’s digital and innovation transformation program, fostering a culture of innovation within the technology teams. Identify opportunities for emerging technologies such as AI, IoT, and blockchain to...

  • Gdt Service Domain Lead Supply Chain Data

    7 months ago

    Durban North, South Africa Aspen Pharma Group Full time

    **JOB PURPOSE** To lead the implementation of enhancements and continuous improvement initiative that enables the development of system solutions to drive Supply Chain efficiency and value creation. To map out business requirements for Supply Chain Planning systems incorporating best practice processes and capability. To lead and direct within the Group...

  • Group Transformation Specialist

    7 months ago

    Durban North, South Africa Aspen Pharma Group Full time

    **JOB PURPOSE** Reporting to the Group Sustainability Manager, the Group Transformation Specialist will support the Group’s broader transformation agenda including the delivery of the Group’s B-BBEE strategy as relates to the South African business. The Group Transformation Specialist will focus on driving performance in respect of the Group’s...

  • Financial Compliance Specialist

    2 weeks ago

    Amanzimtoti, Durban, South Africa Group Technical Security Management Full time

    Job SummaryWe are seeking a highly skilled Financial Compliance Specialist to join our team at Group Technical Security Management.Key ResponsibilitiesInvoicing and project costings: Manage the financial aspects of projects, including invoicing clients and tracking project costs.Supplier reconciliation: Verify and reconcile supplier invoices to ensure...

  • Group Digital Technology Network Operations

    2 days ago

    Durban North, South Africa Aspen Pharma Group Full time

    **ROLE PURPOSE** Operational role in the digital technology organization and is accountable for the provision of network maintenance and support services. Support may be provided both to users of the systems and to service delivery functions. Support typically takes the form of investigating and resolving problems and providing information about the...

  • Group Sustainability Graduate

    7 months ago

    Durban North, South Africa Aspen Pharma Group Full time

    **JOB PURPOSE** Reporting to the Group Sustainability Manager, the Group Sustainability graduate will provide technical and administrative support in the development, execution and reporting in the Group Sustainability and Environmental strategies and projects. **KEY PERFORMANCE AREAS** **Contribute to the Development of a Sustainability Vision, Strategy,...

  • Biorefinery Research Group Lead

    2 weeks ago

    Durban, South Africa MECS Africa Full time

    South Africa, KwaZulu-Natal - Durban - R 800 000 - R 1100 000 Annually Cost To Company My client is seeking a Biorefinery Research Group Lead who will be responsible for leading a team of Scientists and Engineers in developing and exploiting new knowledge, technologies, and human capital to enable renewed development in the forest and waste biomass sectors....

  • IT Technical Buyer

    4 months ago

    Durban, South Africa Games Global Operations Limited Full time

    Overview: The Technical Buyer role will be responsible for tactical sourcing and procurement efforts relating to global spend categories of Information Technology (i.e., hardware, software, data center, cloud, networking, consulting services etc.) to secure optimal opportunities that deliver value, drive savings, increase efficiencies, secure supply,...

  • Group Talent Acquisition Specialist

    2 days ago

    Durban North, South Africa Aspen Pharma Group Full time

    **JOB PURPOSE** Shape the talent acquisition (TA)n strategy to align to the Groups short-medium term business goals, to attract and secure talent for Professional, Senior and C- Suite vacancies, across the Global Micro and Macro Landscape, whilst guiding the achievement of the Groups Equity, Diversity and Inclusion strategy and South African Transformation...