Posted 2 weeks ago

Manager-Quality (LIMS)

Piramal Pharma Limited India, Mumbai, MH
Remote Full Time

Job description

Be the First to Apply 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. Introduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match. Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group. PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.