Dr. Reddy’s Laboratories Ltd. is hiring for the position of Quality Control Associate – LIMS in its Biologics, Quality Control function at Bachupally. The role focuses on LabWare LIMS master data creation, workflow configuration, verification, process mapping, and QC laboratory processes.
Job Details
| Details | Information |
|---|---|
| Company | Dr. Reddy’s Laboratories Ltd. |
| Position | Quality Control Associate – LIMS |
| Function | Quality Control |
| Business Area | Biologics |
| Location | Bachupally |
| Experience | 3+ years |
| Qualification | M.Sc. or B.Tech. in Biotechnology, Microbiology, Biochemistry |
| LIMS | LabWare LIMS |
Position
Quality Control Associate – LIMS
The position requires hands-on experience in LabWare LIMS master data creation, process mapping, master data verification, workflow configuration, and execution of test scripts related to instruments and new modules.
Responsibilities
Key responsibilities include:
- Create, revise, and review LIMS master data.
- Work with specifications, sample plans, test methods, calculations, inventory, schedules, reagent masters, and stability masters.
- Support LIMS workflow configuration, approval workflows, and audit trail requirements.
- Perform challenge testing and verification of configured masters against approved source documents.
- Design and create master data and execute dry runs for verification.
- Perform process mapping of procedures and identify gaps in existing process flows.
- Design logics and verify them through dry runs.
- Execute test scripts for qualification of instruments and new modules as per process flows.
- Communicate effectively with end users, CFTs, and line QA regarding master data.
- Work with QC analytical, microbiology, stability, raw material, packing material, and bioassay testing processes.
- Interpret SOPs, Work Instructions, Specifications, Forms, Validation Reports, Qualification Protocols, and JOS documents.
- Understand and work with change controls, deviations, CAPAs, OOT/OOS requirements, and audit trail review expectations.
Eligibility & Qualifications
Candidates should have:
- M.Sc. or B.Tech. in:
- Biotechnology
- Microbiology
- Biochemistry
- 3+ years of work experience
- Basic understanding of the Biologics/Biosimilar industry, including processes, regulations, and trends.
- Hands-on experience in LabWare LIMS master data creation.
Required Skills
Technical Skills
- LIMS master data creation, revision, and review
- LabWare LIMS
- Process mapping
- Process-flow gap identification
- Master data design and verification
- Dry-run execution
- LIMS workflow configuration
- Approval workflows
- Audit trail requirements
- Test script execution
- Instrument and module qualification
- QC laboratory processes
- Change controls, deviations, CAPA, OOT/OOS
Candidates should also have knowledge of analytical techniques including:
- HPLC
- UPLC
- TOC
- BET
- CE-SDS
- HCD
- HCP
- Particle count
- Environmental monitoring
Behavioural Skills
- Effective verbal and written communication
- Performance-oriented approach
- Ability to maintain high standards
- Flexibility to work in shifts
- Understanding of team dynamics
- Effective communication with end users, CFTs, and line QA