Cleanstep Pharma & Engineering Solutions (Validation/Consulting)
Website:
cleanstep.in
Job details:
Job Title: Caliber LIMS – Master Data Creation ConsultantLocation: Remote / On-site (Pune)
Engagement Type: Contract / Project-based
Industry: Pharmaceutical / Life Sciences / Validation
Job SummaryWe are seeking a skilled Caliber LIMS Master Data Creation Consultant with hands-on experience in configuring and managing master data within Caliber LIMS. The role involves supporting LIMS implementation/expansion projects with a strong focus on GxP compliance, data integrity, and CSV activities.
Key Responsibilities- Configure and create Master data in Caliber LIMS, including:
- Tests, specifications, and test methods
- Raw materials, finished products, and stability samples
- Instruments, equipment, and calibration data
- Define and configure workflows, specifications, and approval cycles
- Align system setup with pharmaceutical QC laboratory processes
- Ensure compliance with:
- GxP guidelines, ALCOA+ principles, 21 CFR Part 11 requirements
- Perform data migration, verification, and reconciliation
- Collaborate with QA, QC, IT, and validation teams
- Prepare documentation for audit readiness
Required Skills & Experience- 3–8 years of experience in Caliber LIMS
- Strong hands-on expertise in master data configuration
- Understanding of pharmaceutical QC workflows
- Experience in regulated environments (USFDA, MHRA, EU GMP)
Preferred Qualifications- Experience in Caliber LIMS implementation or upgrade projects
- Background in Pharmacy / Life Sciences / Engineering
Project Duration6-12 months (extendable)
How to Apply Interested consultants can share their profile at:
Bkadam@cleanstep.in
sbagulwar@cleanstep.in
Click on Apply to know more.