Lab Systems Run Lead

Job Description

Position Title : Lab systems Run Lead

Function : GIDC

Location : GC Bangalore

About Viatris

VIATRIS, is a new kind of healthcare Company, committed to providing access to medicines, advancing sustainable operations developing innovative solutions, and leveraging our collective expertise to improve patient outcomes. Formed in 2020, through the combination of Mylan and Up-John-Pfizer, Viatris bring together best in class scientific, Manufacturing and distribution expertise with proven regulatory, Medical, and commercial capabilities to deliver quality medicines to patients when and where they need it.

Fast Facts

• Headquartered in the US with global centers in Pittsburgh (USA), Hyderabad (India) and Shanghai (China)
• Our global workforce of ~45000, includes expertise across scientific, manufacturing, regulatory and Commercial Operations
• Have ~ 50 Manufacturing Facilities across Oral Solid Doses, Injectables, Complex dosage forms and APIs
• Total 1400+ Molecules, have portfolio that treats nine out of ten WHO causes of death. Our 200+ medicines are on WHO essential medicines List.
• We have commercial reach to 165+ Countries and territories.

Role Purpose

• Subject matter expert and handle run operations for Lab system applications (Labware LIMS v6/v7, Empower/Chromeleon CDS, NuGenesis SDMS and MODA).
• Define procedures or standards, since he/she has the knowledge of what the right or best way to execute a task would be.
• Define performance objectives and determine acceptable performance levels.
• Provide recommendations for procedural improvements.
• Understand the language/terms/jargon in his/her area of expertise.
• Understand requisite knowledge that underlies effective decision-making and is able to describe where anomalies or flaws may occur in the decision-making for his/her area of expertise.
• Act as the go to person within a department or function for questions and problems within his/her area of expertise.
• Explain his/her area of expertise clearly to others.
• Not only answer how things are done, but why.

Key Responsibilities The responsibilities of the SME are to ensure the facts and details are correct so that the project's/program's deliverable(s) will meet the needs of the stakeholders, legislation, policies, standards, and best practices. To achieve this, SMEs will:

• Responsible for day to day run support of lab systems and should be able to manage the team.
• Experience in configuration, administration, and support of scientific applications like Labware LIMS v6/v7, Empower/Chromeleon CDS, NuGenesis SDMS and Lonza Moda.
• Experience in SQL. PLSQL, Crystal reports and good knowledge of SDLS process.
• Knowledge of incident, problem, change management and service requests.
• Experience in handling escalations and addressing them as per business requirements.
• Assist the team with technical and functional knowledge as needed, and prioritize work based on importance and urgency.
• Research and resolve the issues related to system operations and performance.
• Ability to handle multiple responsibilities at any given time, set priorities, schedules, and meet deadlines.
• Provide technical solutions for the Labware LIMS and Empower requirements.
• Experience on compliance activities like periodic review, BAR, DR and UAR.
• Strong analytical and problem-solving skills.
• Ensure that all the Lab system application servers are patched during monthly cycle.
• Address all incidents and service request within SLA and to meet MTTR.
• Extend the run scope and service to new sites.
• Co-ordinate with the project team during the phases of new implementation, migration, and retirement.
• Perform impact assessment for all the infrastructure related activities like (OS upgrade, VDA Components upgrade & Patch) and test application functionalities.
• Identify inefficiencies in the existing processes, develop and implement new process to eliminate these efficiencies.
• Assist with development of new process to support the efficient, effective, and compliant use of lab systems applications.

What we are looking for :

• A passion for working in customer facing roles and have great interpersonal communication, facilitation, and presentation skills.
• 6 to 9 years of experience in a technical support role with bachelors degree in computer science. However, a combination of experience and/or education will be taken into consideration.
• Experience in configuration, administration, and support of scientific applications like Labware LIMS v6/v7, Empower/Chromeleon CDS, NuGenesis SDMS and Lonza Moda.
• Experience in SQL/PLSQL, Crystal reports and good knowledge of SDLC process.
• Pharma template understanding (relationship between item code, sample plan, Analysis, Analysis variation and product).
• Should have knowledge of Labware sample life cycle, integrations with CDS and SAP systems.
• Knowledgeable on CDS applications with instrument configurations, connectivity issues, sample set acquisition, processing, and reporting.
• Should have knowledge of current regulatory & guidelines like 21 CFR part 11.
• Should be familiar with GCP, GLP, GMP guidelines/SOPs and ITIL support model.
• Pharma/Life science domain knowledge and proficiency in English.
• Flexibility to work in non-business hours based on business need/ urgent requests.
• Proficient in the use of Microsoft Excel / PowerPoint for analysis and presentation.
• Excellent communication, presentation, facilitation, time & team management, and customer relationship skills
• Very good experience in conducting Impact Analysis of issues and preparing RCAs.
• Able to follow and participate in technical discussions reviews.