Biocon Biologics | Biocon Biologics | InfoTech_ Expert
3 days ago
Role Summary
The incumbent will be assigned to assess the current level of Industry 4.0 maturity and provide recommendations, Implement/Deliver and continually drive the Maturity roadmap. As part or in isolation assess the need for automation for single or multiple meaningful systems, Implement/Deliver and continually drive the Maturity roadmap.
You will also have opportunity to manage one or more assigned Products for the SW upgrades and Validation. Such as eLOG/MES, VLMS, eCSV Product life cycles (SDLC, Infrastructure, Operability, maintenance) and future road map.
Work closely with the cross functional teams such as Manufacturing, SCM, Quality Control, Quality Assurance etc to understand the business evolution and constantly and continually align the product maturity to commensurate with the business needs. Establish and maintain the budgets (Capex and Opex) pertaining to the assigned Products.
Key Responsibilities
• Perform the Maturity assessment for Industry 4.0 and establish a framework for implementing towards a high maturity. After the framework is established and approved by the Management, work with stakeholders (Internal/External) to implement these on the agreed time and with required standards (Biocon and Regulatory)
• Establish and maintain the assigned product maturity or roadmap.
• Lead the User management and Problem solving.
• Effectively collaborate with Vendor and the AMS teams to establish and maintain the seamless communication and the cohesiveness.
• Time to time hold the meaningful user forum meetings to get the pulse of the Technology adoption, usage and challenges if any; remediate all these quickly and suitably to sustain the digital journey.
• Ensure all the users' needs of the products are met with great satisfaction. C-SAT score expected is 4 out of 5.
• Lead key projects on behalf of IT, working closely with other stakeholders and vendor partners to deliver projects on schedule and cost.
• Track the product backlog and work regularly on remediations/enhancements.
• Secure and manage all the SDLC documentation of the products.
• Ensure Internal audits / external audits / FDA Inspections are the priority and available in person to support quickly.
• Manage products' risks and issues, identify mitigations and workarounds and seek management attention proactively when required.
• Knowledge of software development methodologies such as Agile, SCRUM, and Waterfall for software development initiatives. Working with and interfacing with outside vendors to ensure that all the appropriate resources for any given project are availed at the right time.
• Ability to manage and delegate work as part of a team in a matrix environment.
Year One Critical Success Factors:
• Primary: Successfully completing the Assessment of Current maturity of Industry 4.0
• Secondary: Take over responsibilities of currently implemented systems like eLogbook, eVLMS and eCSV, their SDLC documentation and budgetary needs and road map for the next two years.
• Successfully hold user forum meetings every quarter to get the pulse of adoption and work towards 100% adoption along with C-SAT score of 4 out of 5.
Professional Experience / Qualification:
• Bachelor's in engineering/science or Master's degree in a related discipline, including a minimum of 10-15 years of experience gained in technology implementation/ Product/Project Management in the Pharma space. Definite experience on Industry 4.0 and Industry Automation for minimum of 3-5 years in Pharma space
• Specific experience in working in the Honeywell eLOG/MES and Valgenesis's eVLMS or any other product.
• Experience in working closely with Pharma manufacturing sites.
• Excellent oral/ written communication skills
• Self-starter, with the ability to work and execute independently with minimal oversight.
• PMP Certification preferred but not required.
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