Job Opportunities at Aspen Pharma Group

Description
Overview

• Manage and support production processes and outputs
• Long term production and shift planning
• Problem identification and solution engineering
• Manage and guide production staff through team leaders
• Performance management of direct reports, monitoring of performance management within department

Requirements

• Responsibilities Planning and Unit Management
• Provide technical and operational input into processes, procedures and policies
• Coordinate the communication, management, and implementation of strategic plans and monitor implementation
• Build and maintain relationships with internal and external stakeholders Develop, implement, and monitor Focus Factory operating budgets
• Ensure availability and optimal allocation of resources within unit
• Perform HR functions for optimal management of unit
• Empower subordinates through training, information sharing, coaching, feedback, appraisals, and delegation, to ensure the development of people, teams, and organisational capabilities
• Attend production, quality and safety meetings Production Planning and Process Management
• Ensure operational excellence with regards to safety, quality, and productivity of the Focus Factory, and its ability to deliver high levels of service to internal and external customers
• Manage people, materials, equipment, business and manufacturing processes to deliver Factory performance objectives, as measured by factory KPI's
• Ensure compliance with policies/procedures for shift rotation, vacation scheduling, and training to meet business needs including peak production periods
• Manage the development and implementation of daily production schedule to ensure high levels of OTIF to internal and external customers
• Ensure effective implementation of new technology and products
• Implement TPM and other continuous improvement programs
• Develop and implement CAPEX budgets Ensure integrity of business processes related to finished goods inventory replenishment, and new product introductions Governance, Risk & Compliance
• Ensure adherence and compliance to regulatory requirements
• Ensure that appropriate validations are completed as per validation requirements and schedule
• Initiate and set targets, and review GMP, quality and training needs

Requirements Background/experience

• Minimum of Bachelor’s degree preferred, ideally in Pharmacy/ Engineering/ Chemistry with 10 years’ related experience
• Pharmaceutical manufacturing experience
• Project Management experience Management of business initiatives
• 8-10 years of proven leadership capability and managerial experience at a senior level Specific job skills
• Strong working knowledge of pharmaceutical manufacturing
• Problem solving and solution engineering
• Pharmaceutical standards and compliance requirements
• Coaching, leadership and mentoring
• Ability to interpret and implement policies, processes and objectives Competencies
• Offering Insights
• Making Decisions
• Managing Performance Customer Awareness
• Developing Others Accountability & Decision Rights
• Develop, communicate, manage and implement corporate and divisional strategic plans and budgets, policies and procedures Independent decisions relating to:
• Design and implementation of strategy for programmes/ processes
• Interpretation and execution of and recommendations on policy/ procedure related modifications
• Short and long term department schedules, quality, compliance and resource allocation
• Operation objectives and work plans, and delegation of assignments

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Description
Overview

• Provide expert inputs and lead the resolution of problematic scientific investigations in the QC Lab.
• Review emerging analytical technologies, assess feasibility, establish a business case and implement best practices when necessary.
• Provide expert scientific coaching to analytical teams.
• Develop systems and processes for conducting investigations within GMP requirements.
• Evaluate analytical equipment and techniques.
• Reduce Laboratory OOS with effective Preventative Actions

Requirements
Responsibilities

• Troubleshooting and Deviations Investigations
• Lead all scientific investigations within the QC Lab for raw material, finished product, packaging, analytical method development / validation and stability testing.
• Troubleshoot and identify the root cause of analytical issues encountered during analysis.
• Lead the identification, investigation and reporting of OOSs, deviations, and other nonconformities according to GMP requirement and SOPs.
• Generate scientific motivations in response to Regulator findings and queries.
• Identify OOS data trends to establish any systematic issues in process, testing, calibration or maintenance
• Implement plans to reduce and mitigate OOSs and enhance right first time performance.
• Perform impact and risk assessments of CAPA plans on process
• Implementation and development of improvement initiatives designed to increase lab productivity and customer services
• Provide analytical support to Aspen Group and AGI.
• Collaborate across Aspen sites to ensure growth and development within the QC Lab.
• Anticipate and critically evaluate scientific or regulatory advances and respond with appropriate new strategies.
• Keep up to date on latest developments within laboratory systems in order to understand how the applications can be further leveraged to meet business needs.
• Assist with improving analytical method development by implementing the concepts of lifecycle management and Quality by Design (QbD).

Requirements Background/experience

• Graduate Degree/ Diploma in Chemistry/ Analytical Chemistry with 10 to 15 years’ related experience.
• Experience in quantitative and instrumental analysis in QC and laboratory environment Specific job skills
• Extensive experience in scientific principles and laboratory techniques and methodologies
• Scientific report writing skills Understanding of pharmaceutical manufacturing, standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives
• Thorough knowledge of Pharmaceutical analytical issues, manufacturing processes and operations environment, including a detailed knowledge of validation, regulatory affairs, R&D, and new product transfer Competencies
• Information Interpretation
• Interrogating Information
• Offering Insights
• Investigating Possibilities
• Creating Clarity
• Navigating Complexity
• Problem Solving

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Overview

• Strategic and tactical role in the digital technology organisation and is accountable, in the domain of this position, to manage the provisioning and support of reliable secure software applications and services which support business capabilities and are easily re-used, maintained and updated to meet current and future organisational needs.  Responsibilities include stakeholder identification and relationship management, application life-cycle management, requirements management, business process definition, content authoring and user training, investigation of operational issues, problems, measuring and managing related service contract performance and finding new opportunities in effective business solutions through improvements in aspects of business operations and business systems.

Responsibilities

Stakeholder management

• Identify stakeholders for the IT services provided within domain of this position, to engage, manage and monitor the relationship and stakeholder communications, to agree on mutually beneficial outcomes and getting commitment to action through consultation
• Deals with problems and issues, managing resolutions, corrective actions, lessons learned, and the collection and dissemination of relevant information.
• Implements stakeholder engagement/communications plan. Collects and uses feedback from customers and stakeholders to help measure the effectiveness of stakeholder management.
• Helps develop and enhance customer and stakeholder relationships.
• Skills: Relationships and Engagement – Stakeholder Relationship Management (Level 4 – Enable)
• To align the technology strategy for the IT services provided within the domain of this position with the business mission, strategy, and processes and documenting this using architectural models while identifying and assessing new and emerging technologies, products, services, methods and techniques
• Interpreting business goals and drivers and translating business strategies and objectives, assessing current capabilities and identifying required changes in capabilities to achieve objectives
• Contributing to creating and reviewing systems capability strategy, reports and technology roadmaps and the sharing of knowledge and insights
• Supports monitoring of the external environment and assessment of emerging technologies
• Develops models and plans to drive business efficiency taking advantage of opportunities to improve performance

Business Process Management

• Define, evaluate and describe business processes, identify change options, and evaluate the financial, technical and business feasibility within the domain of this position
• Understanding the purpose and benefits of modelling using established techniques, as directed, to model simple subject areas within the domain of this position
• Describing the interrelationships between people, organisation, service, process, data, information, technology and the external environment in iterations of architectural models and views
• Determining requirements for and specifying effective business processes, through improvements in technology, information, or data practices, organisation, roles, procedures and equipment.
• Ensuring defined models are aligned with the business vision, mission, objectives and strategy by engaging with relevant stakeholders and specialists and evaluating for financial, technical and business feasibility
• Employ standard techniques to get information required for feasibility assessment and support identification of tangible costs and benefits in development of business cases

Customer Requirements

• To manage the business requirements within the domain of this position throughout the entire delivery and operational life cycle
• Eliciting and documenting functional and non-functional requirements
• Ensuring customer requirements are accurately reflected
• Review and validating these requirements for errors, omissions, and any constraints, and negotiating trade-offs that are acceptable to key stakeholders within budgetary, technical, regulatory and other constraints

Knowledge sharing

• Controls, monitors, and evaluates content to ensure quality, consistency and accessibility of messages and optimal use of chosen media. Understands and manages risks associated with publishing content.  Moderates content and ensures content can be re-purposed appropriately.  Reviews work of others and takes responsibility for ensuring appropriateness
• Systematically capturing, sharing, developing and exploiting the collective knowledge of the organisation
• Supporting a knowledge sharing culture to drive the successful adoption of technology solutions
• Facilitating internal and external collaboration and communications
• Establishing and supporting Centers of Excellence
• Capturing, organising and developing information and knowledge from employees, customers and external partners
• Produce knowledge base articles that are accurate, current, relevant and easily understood by the intended audience.
• Clarifies detailed content requirements with customers and representatives of the intended audience
• Designs, creates, controls and evaluates moderately complex subject matter.
• Makes informed decisions about the best way to present information to an audience.
• Contributes to knowledge management systems to meet business needs

Service Delivery

• Deliver management, technical and administrative services to support and maintain the applications and implement security controls and security management strategies within the domain of this position
• Ensures that all requests for support are dealt with according to set standards and procedures
• Drafts and maintains procedures and documentation for applications support
• Manages application enhancements to improve business performance
• Monitoring performance of applications
• Advises on application security, licensing, upgrades, backups, and disaster recovery needs
• Adherence to established safety, security and quality standards
• Authorises and monitors access to applications and investigates unauthorized access
• Defining and reviewing access rights and privileges and the application and operation of elementary physical, procedural and technical security controls
• Maintain the validated state of the IT systems in alignment with Computer System Validation (CSV) policies and procedures
• Contributes to / leads the successful delivery of IT Projects to implement, change, test and/or upgrade the relevant IT systems

SLA Management

• To obtain formal confirmation that IT service acceptance criteria have been met, agreeing targets for service levels and assessing, monitoring, and managing the delivery of IT services against the targets, including the contractual performance objectives (cost effectiveness, efficiency and service quality) of domain specific IT products and services as provided by suppliers
• Engages with delivery teams to confirm that products developed meet the service acceptance criteria, including functionality, operational support, performance, safety, security and quality requirements
• Negotiates, implements and monitors service level agreements and ensures the service provider is ready to operate the new service when it has been deployed
• Monitors and logs the actual service provided, compared to that required by service level agreements
• Identifies opportunities to improve service delivery / Continuous Service Improvement (CSI)
• Acts as a routine contact point between the organisation and suppliers concerning contract management.
• Supports the collection of contract performance data and creates standard reports on contract performance
• Collects supplier performance data and investigates problems
• Monitors and reports on supplier performance, customer satisfaction, adherence to security requirements and market intelligence and validates that suppliers' performance is in accordance with contract terms.
• Manages performance and risks across multiple suppliers (internal and external) using a set of agreed metrics
• Engages proactively and collaboratively with suppliers to resolve incidents, problems, or unsatisfactory performance

Incident Management

• To coordinate responses to reported incidents, minimising the negative impacts and restoring service as quickly as possible.  Managing the life cycle of all problems that have occurred or could occur in delivering a service.  Assessing risks associated with proposed changes and ensuring changes to products, services or systems are controlled and coordinated.
• Ensure that incidents are handled according to agreed procedures to investigate causes, seek resolution and escalate when required
• Monitors resolution activity and facilitates recovery of processes
• Informs users, customers and key stakeholders of progress towards service restoration
• Ensure user feedback is captured and analysed to inform future decisions
• Initiate and monitor actions to investigate and resolve problems (proactively and reactively) in systems, processes and services, determine problem fixes and remedies
• Collaborate with others to implement agreed remedies and preventative measures and support analysis of patterns and trends to improve problem management processes
• Assess, analyze, develop and implement changes based on requests for change including risk assessment and mitigation, document version management and methods to report on the lifecycle of change requests

Project Management

• Delivering agreed outcomes from projects using appropriate management techniques, collaboration, leadership and governance.
• Defines, documents and executes small projects or sub-projects.
• Works alone or with a small team actively participating in all phases of the project. Applies appropriate project management methods and tools. Identifies, assesses and manages risks effectively.
• Agrees project approach with stakeholders and prepares realistic project plans (including scope, schedule, quality, risk and communication plans). Tracks activities against the project schedule, managing stakeholder involvement as appropriate.
• Monitors costs, times, quality and resources used takes action where these exceed agreed tolerances.

Training and Developmemt

• To provide guidance or training to users — including enhanced levels of support following new/updated software releases – through structured curricula, transferring of knowledge, developing skills and changing behaviours using a range of techniques, resources and media
• Contributes to delivery of aspects of user curricula e.g. end user training content creation and applies good practice in learning content design, development and delivery
• Performs a range of learning activities to support the delivery of learning objectives through a range of techniques, resources and media including — but not limited to — face-to-face learning, e-learning, on-line virtual environments, field-work and projects, self-assessment, peer-assisted learning, simulation
• Assists with maintaining user competence through delivery of training by observing learners perform practical activities and work, and providing assistance within routine enquiries and escalation where needed
• Assists with hypercare and user adoption support following new/updated software releases

GxP Compliance

• Perform all duties in compliance with the relevant GxP and cyber security guidelines, standards, polices and procedures
• Ensuring compliance with relevant guidelines and legislation through adherence to defined Standard Operating Procedures and other ways of working
• Identify gaps in procedural documentation and suggest improvements where required
• Monitoring violations of security policies, analysing relevant logs, alerts and events
• Responding to incidents according to procedures and maintaining the related security records and documentation

Requirements
Background/experience

• Tertiary Qualification in IT or related Business qualification
• Current industry certification (ITIL, TOGAF, GXP, etc.)
• Formal Business Analyst qualification advantageous
• Business Process Management Methodology (BPM / BPMN 2.0, SDLC, etc.)
• Enterprise Architecture (TOGAF, Archimate, etc.) and project / implementation Methodologies (PRINCE II, PMBOK, Agile, etc.) will be an advantage
• 4 – 7 years Business Experience within the specific domains
• 2 – 5 years IT Functional Support in Pharma or equivalent experience

Specific job skills

• Experience managing internal customer relationships
• Experience and sound knowledge of business processes, quality management and customer support practices and improvement practices
• Experience leading and influencing customers and matching needs to solutions

Competencies

• Create the future
• Performance Driven
• Accountability/ Ownership        
• Communicate Effectively
• Dealing with ambiguity Embrace Change          
• Contribute Special Expertise
• Take Action with Integrity