Application Support – L2 | R&D and QC Lab Applications

Application Support – L2 | R&D and QC Lab Applications

Experience: 4–6 Years
Location: Bangalore
Work Model: 100% Work From Office
Rate: Approximately INR 8,200/day

Position Overview

We are looking for an experiencedApplication Support – L2 professional with hands-on experience supportingR&D and QC Laboratory applications. The candidate will be responsible for providing L2 application and IT support for Scientific, R&D, and Quality Control systems, ensuring business continuity, regulatory compliance, data integrity, and adherence to defined IT and GxP processes.

Key Requirement

• Experience providingL2 support for R&D and QC Lab applications.
• Candidates should have relevant experience supporting Scientific and Quality Control applications in a regulated environment.
• Experience with GxP systems, computerized system validation, IT compliance, and laboratory applications will be preferred.

Key Roles and Responsibilities

Application and System Administration

1. Maintain inventory of all Scientific (R&D) and QC applications at the respective site.
2. Prepare and maintain IT-related SOPs, as applicable, for QC and Scientific automated systems.
3. Provide IT administrative support for QC and Scientific systems, including:
   • User management, including user creation, modification, password reset, etc.
   • User access rights management.
   • Active user list preparation.
   • Date and time management.
   • Backup and restoration management.
   • Periodic review of event logs, where applicable.
   • Support vendors/OEMs in resolving IT-related issues during breakdowns.
4. Perform data and program backup and retrieval of Scientific and QC systems as per application SOPs.

Quality, Compliance and Documentation

1. Adopt, create, and maintain Quality Management Procedures as per IT operational requirements.
2. Act as the first-level point of contact for all IT-related queries from Scientific Informatics Support at R&D locations.
3. Ensure adherence to organizational, site, and department IT policies, guidelines, and procedures, while maintaining accurate documentation.
4. Conduct training for business users on various applications during rollouts and as needed.
5. Assist in21 CFR Part 11 assessments during Computerized System Validation activities.
6. Perform, participate in, and assist with qualification and validation ofGxP applications from an IT perspective.
7. Participate in and complete periodic reviews of GxP systems from an IT perspective.

Incident, Change and Problem Management

1. Coordinate with centralized IT teams, vendors, service providers, and business functions to resolve application, service, and functional issues related to Scientific and QC systems.
2. Analyze new business requirements and implement solutions in consultation with cross-functional teams and BBL management.
3. Coordinate with R&D and QC functional teams to identify root causes (RCA) from an IT perspective for incidents and CAPAs.
4. Implement change controls and log incidents and deviations related to IT functions in R&D and QC units.
5. Ensure adherence to defined SLAs for IT administrative support activities.

Audit and Regulatory Support

1. Represent IT during regulatory, customer, and internal inspections, and coordinate with site IT or centralized teams to provide required inputs and information.
2. Prepare, review, and implement audit findings identified during internal, customer, third-party, and regulatory inspections.
3. Coordinate with audit response teams to address audit observations identified during inspections.
4. Implement CAPAs (Corrective and Preventive Actions) identified through internal and external audits.

Service Delivery and Continuous Improvement

1. Provide internal and external IT solutions and services related to QC and R&D systems.
2. Deliver IT solutions and services that are business-critical, regulatory-compliant, and support consumer safety requirements.
3. Conduct service reviews, process evaluations, benchmarking activities, and continual service improvement initiatives.

Required Application Experience

The candidate should have experience supporting one or more Scientific, R&D, QC, laboratory, chromatography, analytical, instrument control, data management, or laboratory information applications from the following environment.

Laboratory Information and Scientific Applications

• LIMS
• ELN
• SDMS
• LabSolutions Manager
• Lab Solutions
• OpenLab Control Panel
• OpenLab ChemStation Control Panel
• ChemStation and Plugins
• OpenLab ChemStation
• OpenLab Old
• Analyst Software
• DYNAMICS
• Astra
• Omega
• Stability Control Setup
• SCIMED TMS Application
• Stability Control & SCIMED
• TMS Sentry 256
• Q-Capture Pro 7
• QX Manager
• Easy Log
• Eazy Reader GXP
• Data Translation Open Layers

Chromatography and Analytical Systems

• Chromeleon
• Thermo Chromeleon 7.2.10
• Thermo Xcalibur
• Thermo XCAILBUR
• MASSLYNX
• Waters_connect Hub
• 32 Karat
• Compass ICE
• Bruker Compass HyStar 5.1
• Bruker Compass Data Analysis 5.1
• Bruker Flex Control
• ChroMIQ v7.1 NLib
• ChromLab
• WinISO E1202 PB4
• KF COMM 2

Bioprocessing and Cell Analysis Applications

• UNICORN
• Unicorn 5.31
• UNICORN 5.3
• UNICORN 7.3
• Unicorn 7.7
• Ambr
• Ambr 250
• Ambr Crossflow
• CEDEX BIO HT 6.0.0
• CEDEX 2.5
• Vi-Cell XR
• Vi-Cell Blue
• Vi Cell UI
• Vicell Blu
• MFCS WIN
• MFCS Shell
• MVS
• ProteinSimple MVSS
• Solentim Cell Metric Version 3.3.0
• Cryopilot 5
• Client FACSUITE

Molecular Biology and Imaging Applications

• GEN 5 / Gen5
• Gen 5 1.10
• SoftMax Pro 7.1.1 GxP
• SoftMax Pro 7.0.3 GxP
• Bio-Rad CFX Maestro 2.3
• REALPLEX
• MX Pro
• QuantStudio™ Design & Analysis Software
• QUANTA.SOFT
• 7500 Software
• Image Lab 5.2.1
• Image Lab 6.0
• NIS-Elements 4.20.03
• NIS-Elements F 4.60.00
• LabChip GX Reviewer
• LabChip GX Touch
• EndoScan V
• DECYDER 2D

Biacore and Protein Characterization Applications

• Biacore T200 Control Software
• Biacore T200 Evaluation Software
• Biacore 8K Control Software
• Biacore Insight Evaluation Software
• Biacore 8K & Insight Software
• ForteBio GxP Server & Data Analysis
• PMI – Peptide
• PMI – Intact
• Uncle Analysis & Uncle Client
• MicroCal VP – Capillary DSC Software 4.2
• NanoAnalyse
• Nano DSC Run
• PrimeView and Evaluation
• Pressure Biosciences 2320 EXT

Instrument Control and Other Scientific Applications

• Agilent Aria 2.0
• Agilent Cary WinUV Firmware Patch 1.0
• Cary Eclipse WinFLR
• Cary Eclipse WinFLR
• C Technologies SoloVPE Software
• Density Meter
• Thermo SOLAAR
• FREEDOM EVOware
• EvoWare Standard
• Spectra Manager
• NanoDrop 2000
• NanoDrop One PC
• Morphologi Version 10.30
• Osmometer
• PLA
• iFIX
• Emperor (Torque)
• Instron Bluehill Universal
• Methodical Mind Reader S600
• Kuhner Insight 4034
• Celsius Software
• Venus Software
• x.sight
• Lyophilization Control and Freeze Dryer Data Plot
• LABsolutions UV-VIS
• Biacore applications and associated evaluation software

Preferred Skills

• Strong experience inL2 Application Support.
• Experience supportingR&D, QC, Scientific, and Laboratory applications.
• Knowledge of laboratory systems, instrument software, and Scientific Informatics applications.
• Experience in user administration, access management, backup and restoration.
• Knowledge ofGxP,21 CFR Part 11, and Computerized System Validation.
• Experience in qualification and validation of computerized systems.
• Knowledge of incident management, change control, deviations, RCA, CAPA, and SLA management.
• Experience supporting regulatory, customer, internal, and third-party audits.
• Strong coordination skills with business teams, centralized IT teams, vendors, and OEMs.
• Good documentation and SOP management skills.
• Ability to work effectively in a100% Work From Office environment.

Candidate Profile

The ideal candidate will have4–6 years of experience in Application Support, preferably in a pharmaceutical, biotechnology, life sciences, laboratory, or other regulated environment. Candidates with hands-on experience providingL2 support for R&D and QC Laboratory applications, along with exposure to GxP compliance and Scientific Informatics systems, will be highly relevant for this requirement.

Priority Requirement: Candidates should closely align with the R&D and QC Lab application support environment and possess relevant hands-on experience with Scientific and QC systems.