Manager-Quality (LIMS)

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Division

Piramal Pharma Solutions

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.