Manager 1 -LIMS Implementation And Integration Manager

SUN PHARMA; Vadodara; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Sun Pharma is seeking a senior LIMS implementation lead to own end-to-end delivery of CaliberLIMS-based programs, aligning lab operations with business goals and regulatory requirements.

You will lead requirements gathering, design, configuration, and integration with SAP/TrackWise, ensuring CSV and 21 CFR Part 11 compliance, training users, and driving post-go-live improvements.

Qualifications

• 7-10 years of experience in LIMS implementation in regulated environments.
• Strong knowledge of QC/R&D lab workflows.
• Experience with system integration and data architecture.

Responsibilities

• Own end-to-end delivery of LIMS (CaliberLIMS Preferred) implementation programs, ensuring alignment with laboratory operations, business goals, and regulatory requirements.
• Lead requirement gathering, solution design, and system configuration including workflows, and user roles/permissions.
• Manage project planning, timelines, risks, & resource allocation to ensure successful and timely delivery.
• Drive integration of LIMS with Lab Instrument including Port based, File based and CDS (Empower) and enterprise systems (such as SAP and TrackWise) ensuring data integrity and system performance.
• Ensure compliance with GxP standards (GMP, GLP, FDA, 21 CFR Part 11) and lead Computer System Validation (CSV) activities.
• Act as the primary liaison between business stakeholders, IT teams, QA, and external vendors, ensuring clear communication and alignment.
• Lead user enablement including training strategy, SOP development, documentation, and change management for successful adoption.
• Establish post-go-live support, continuous improvement initiatives, and system enhancements to optimize performance and user experience.

Skills

LIMS implementation

CaliberLIMS

Regulatory compliance (GxP)

CSV (Computer System Validation)

System integration

Data architecture understanding

Education

Bachelor's degree in Information Technology or Computer Science

Tools

SAP

TrackWise

CaliberLIMS

Job description

Job Description:

Job Summary

At Sun Pharma, we commit to helping you "Create your own sunshine" - by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you'll find yourself becoming 'Better every day' through continuous progress. Exhibit self-drive as you 'Take charge' and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we 'Thrive together' and support each other's journeys.

Areas Of Responsibility

• Own end-to-end delivery of LIMS (CaliberLIMS Preferred) implementation programs, ensuring alignment with laboratory operations, business goals, and regulatory requirements.
• Lead requirement gathering, solution design, and system configuration including workflows, and user roles/permissions.
• Manage project planning, timelines, risks, & resource allocation to ensure successful and timely delivery.
• Drive integration of LIMS with Lab Instrument including Port based, File based and CDS (Empower) and enterprise systems (such as SAP and TrackWise) ensuring data integrity and system performance.
• Ensure compliance with GxP standards (GMP, GLP, FDA, 21 CFR Part 11) and lead Computer System Validation (CSV) activities.
• Act as the primary liaison between business stakeholders, IT teams, QA, and external vendors, ensuring clear communication and alignment.
• Lead user enablement including training strategy, SOP development, documentation, and change management for successful adoption.
• Establish post-go-live support, continuous improvement initiatives, and system enhancements to optimize performance and user experience.

Travel Estimate

70%

Job Scope

Internal Interactions (within the organization): Yes with CFTs

External Interactions (outside the organization): Yes with Vendor

Geographical Scope: NA

Financial Accountability (cost/revenue with exclusive authority): NA

Job Requirements

• Educational Qualification: Bachelor's degree in Information Technology, Computer Science,
• Specific Certification: NA
• Experience: 7-10 Years
• Skill (Functional & Behavioural):
• 7-10 years of experience in LIMS implementation, with exposure to regulated environments such as pharmaceuticals or biotechnology.
• Strong expertise in LIMS platforms (CaliberLIMS preferred) and understanding of laboratory workflows (QC/R&D).
• Proven experience in system integration (instruments and enterprise applications) and basic understanding of data architecture.
• In-depth knowledge of regulatory compliance (GxP, FDA, GMP, GLP, 21 CFR Part 11) and Computer System Validation (CSV).
• Strong leadership, stakeholder management, communication, and problem-solving skills with the ability to manage multiple priorities.

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together!

Requirements: