Manager-Quality (LIMS)

Piramal Pharma Ltd; Mumbai; On-site; INR 3,200,000 - 4,800,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Manager-Quality (LIMS) to support its LIMS Center of Excellence across sites. You will manage master data records, troubleshoot LIMS issues, and coordinate with QA and IT to maintain data integrity after Go-Live.

The role requires 5–10 years in LIMS/matter with LabWare experience, and strong cross-functional collaboration skills to drive standardization and continuous improvement.

Qualifications

• Graduate / Post-Graduate in Science/ B. Pharm/ M. Pharm or relevant technical qualification with minimum of 5–10 years of relevant experience.
• Hands-on experience with LIMS platforms (Preferrable LabWare) and master data management.
• Clear communication and collaboration with stakeholders.

Responsibilities

• Develop and implement procedures for maintaining and updating master data records in alignment with quality standards.
• Support master data management processes within the LIMS, ensuring accuracy and consistency of master data.
• Monitor tickets and SLA adherence after going live.
• Coordinate with business and LabWare for change requests post Go-Live.
• Provide troubleshooting support to LIMS users and address issues promptly.
• Escalate complex technical issues to IT or support teams for resolution.
• Monitor LIMS performance and identify improvement areas.
• Facilitate cross-site coordination to ensure standardized LIMS processes.
• Develop training for lab personnel and new LIMS users.
• Foster continuous improvement culture within the CoE.

Skills

LabWare LIMS

Master data management

GxP & 21 CFR 11

Troubleshooting

Education

Graduate / Post-Graduate in Science / B.Pharm / M.Pharm

Tools

LabWare

Job description

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Manager-Quality (LIMS)

Job Description

LIMS center of Excellence for PPL sites. Supports in master data management and LIMS trouble shooting after implementation of LIMS.

JOB OVERVIEW

LIMS center of Excellence for PPL sites. Supports in master data management and LIMS trouble shooting after implementation of LIMS.

KEY STAKEHOLDERS: INTERNAL

Site Quality and IT, Corporate functions

KEY STAKEHOLDERS: EXTERNAL

OEM

REPORTING STRUCTURE: (Reports To/ Direct Reports Y/N)

Reports to chief Manager central Quality. No direct reports

Essential Qualification

Graduate / Post-Graduate in Science/ B. Pharm/ M. Pharm or relevant technical qualification with minimum of 05-10 years of relevant experience

Relevant Experience

• Basic understanding of QC laboratory workflows, laboratory instruments and the data they generate.
• Ability to work effectively with cross-functional teams.
• Hands-on experience with LIMS platforms (Preferrable LabWare), master data management.
• Clear communication and collaboration with stakeholders.

Admin-1 certification from LabWare would be preferred.

SHIFT:

Flexi considering the support required to three time zone (India, US, UK)

Key Role And Responsibilities

• Develop and implement procedures for maintaining and updating master data records in alignment with quality standards.
• Support master data management processes within the LIMS, ensuring the accuracy and consistency of master data sets.
• Monitoring of tickets and SLA adherence after going live.
• Conduct meeting with business and LabWare for change request or recurring issues as needed post Go-Live.
• Provide troubleshooting support to LIMS users, addressing common issues and inquiries in a timely manner.
• Escalate complex technical issues to the appropriate IT or support teams for resolution.
• Monitor the performance of the LIMS and identify areas for improvement.
• Facilitate communication and coordination between sites utilizing the LIMS, ensuring consistency and standardization in processes and procedures.
• Promote cross-site learnings and best practice sharing to leverage insights and successes across different locations and teams utilizing the LIMS.
• Develop training module and conduct sessions for laboratory personnel / new users of the LIMS, covering basic system functionalities, data entry procedures, and laboratory processes.
• Foster a culture of continuous improvement within the CoE, encouraging team members to contribute ideas for enhancing LIMS processes and functionalities.

Any other activity as assigned by the HOD.

Key Competency

• Proficient in LabWare LIMS master data management, workflows, and templates.
• Analytical and troubleshooting skills for resolving system issues.
• Knowledge of GxP, 21 CFR Part 11, and data integrity standards.