- 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.
