AstraZeneca Pharmaceuticals LP Business Analyst - MES in Chennai, India

Job Description / Capsule

The Manufacturing Execution System (MES) Business Analyst has experience performing IT business analysis within a multi-system manufacturing environment, working with key business stakeholders. The MES Business Analyst has a broad and deep understanding of manufacturing business processes, and can drive standard best practice approaches to implementation across multiple pharmaceutical and biologics production technologies at facilities with diverse geographies, regulatory requirements, and cultures.

The MES Business Analyst will be accustomed to adapting to a variety of complex situations within plants where manufacturing processes and equipment differ, and be able to work strategically keeping the enterprise solution in mind. The MES Business Analyst operates with a high level of interactive communication to set clear direction for others, demonstrating high levels of inclusion and cultural sensitivity.

The role will partner with the local and global Business Process Owners (BPO) of the Manufacturing Execution process. In this partnership, the MES Business Analyst will be an active member of governance boards, supporting the BPO in driving the adoption of standard AstraZeneca processes across the manufacturing site network.

The MES Business Analyst will take a best practice approach to process documentation, maintaining a comprehensive set of standard and site process flows (ex: swim lane diagrams). They will also work closely with the manufacturing architects and engineering to ensure the business processes deployed in MES are underpinned with the appropriate technology, and the users’ needs are supported.

The MES Business Analyst will be an active participant in an MES Center of Excellence. In this role they will work closely with other site based MES specialists, informing on Master Batch Record / Generic Master Batch Record (MBR/GMBR) best practice design principals. The design principals will align with the standards established by both the MES BPO and Quality MBR BPO standards.

Typical Accountabilities

The MES Business Analyst is expected to perform at expert level in the following:

Business Needs Identification - Operates at an enterprise level in assessing and defining business need and areas for improvement. Proactively seeks out opportunities to enhance and improve in line with strategic goals. Actively monitors and identifies capability gaps and proposes potential solutions through research internally and externally.

Business Process Mapping - Selects the appropriate documentation approach depending on process type. Proficient in scoping and recommending appropriate approaches. Capable of planning and managing their own and other team member’s activities to meet deliverables and deadlines. Accountable for performance and quality of analytical work delivered, both their own and the work of others.

Stakeholder Analysis & Change - Effectively identifies stakeholders from all areas of the business, and actively builds and maintains relationships according to individual stakeholder needs and levels of influence. Contributes to communication plans and change management for project and stakeholders.

Business Solution Assessment - Highly proficient in analyzing and assessing solution proposals and able to articulate supporting reasoning. i.e. assessing business readiness, maximizing value vs. spend. Leads the work with the business to identify functional and technical and GMP compliance requirements, translating the requirements into design specifications reflecting Functional Design, User Interface Design and Business Process Modelling. Closely partnering with the Architecture team, ensuring the technical solution will deliver the agreed business benefits.

Manufacturing and Packaging Processes - Has a diverse set of experiences with shop floor manufacturing environments, preferably in a Pharmaceuticals, Biologics or life sciences. Understands the importance of the user’s role in executing the manufacturing process, their interaction with electronic systems, and the constraints they face when performing their duties.

Work collaboratively with

Senior Business Stakeholders to ensure that solutions fulfil their future strategic needs and challenges Business Process Owners to develop and maintain the business relationship, support business process change and act as point of contact for MES deployment and change Site Business customers to identify business needs, mentor local MES staff, and effectively communicate impact, cost and benefits of new and changed demands IT Delivery and Support to ensure clear understanding of requirements and effective testing so that the solutions delivered to the business are efficient and effective, meeting the customer experience expectations. Site and Global Engineering Teams to ensure that specified line equipment is able to integrate seamlessly with the AstraZeneca standard solution for MES

Work collaboratively with or take responsibility for:

Test Lead to define the testing approach and the components of testing to ensure traceability of requirements and effectiveness of overall solution. Change Management/Communication Lead to ensure the Change Management and Communications plans and delivery support the Stakeholder Analysis.

Education, Qualifications, Skills and Experience

Essential

  • Proven experience of working with complex integrated systems, using creative and strategic thinking to deliver exceptional results.

  • Strong engagement, communication and stakeholder management skills, including excellent presentation and influencing skills at senior levels

  • Experience of mentoring, coaching or developing others

  • Experience of working with and managing third party suppliers/vendors

  • Experience of managing high levels of risk by making reasoned judgements of complex situations, developing innovative solutions and applying comprehensive cross-functional and industry understanding.

  • Experience with Manufacturing Execution Systems

  • Experience with production processes within Enterprise Resource Planning systems such as SAP

  • Degree in relevant engineering or IT discipline

Desirable

  • Exposure to User Centred Design (User Experience, User Interface and Business Process Engineering)

  • Lean SIGMA training

  • Practical usage of Agile Methodology

  • Experience of working in a global organisation with complex/geographical context

  • Working in a highly regulated industry

  • Pharmaceutical business awareness

  • Cross industry business awareness

  • Proven experience of successfully deploying MES technology in a regulated manufacturing environment

  • Through understanding of industry standards for enterprise and control system integration such as ISA95 and S88

  • Experience with production automation systems

  • Experience with the Werum PAS|X MES system

  • Experience with Data Historian Systems

Key Stakeholders

Internal (to AZ or team)

  • IT Capability Leads

  • Business Relationship Managers

  • Business customers

  • Global process and systems owners

  • Enterprise and Solution Architecture

  • Strategy, Innovation, Delivery and Capability functions

  • Capability Service Managers and Operational Service Managers

  • Cross functional project teams

  • Internal network forums

External (to AZ)

  • External IT partners, Third Party suppliers/vendors

  • Consultancy partners

  • MES professional bodies, networks and forums

  • Business specialism professional bodies, networks and forums