Manager- Quality

1 week ago

Mumbai, India Piramal Group Full time

Business: Piramal Pharma Solutions Department: Quality Location: Kurla Travel: Low Job Overview: Remote support to PPL sites in reviewing analytical data remotely, preparing master build in LIMS (Lab Vantage / Labware), Document Preparation (specifications, test methods, protocols, etc.) and uploading for review in ensure, initiating QMS elements in Trackwise / eDMS. Key Stakeholders: Internal Site Quality Team (QC, QA), Corporate Functions Key Stakeholders: External  Regulators (during inspection), Solution Providers Reporting Structure PPL Site Quality (Functionally) and CQA Document, Data Review & Creation (Administratively) Qualification B. Pharm / M. Pharm / Chemistry / Chemistry or equivalent/Microbiology Experience •Need to be ready to live and embrace the Piramal values. •Quality professional with + years of QC / QA experience in a regulated pharma companies. •Must have hands-on experience in Laboratory software's, testing, applications and systems (Chromatography By HPLC and GC, UV, IR, Dissolution, Malvern, KF auto titrator, etc). •Must have worked in LIMS for Data entry / master build, and data review. •Knowledge of applicable regulatory requirements / regulations (USFDA, EU, Health Canada, others). •Need to be aware of latest regulations and pharmacopeial requirements. •Well-organized and committed, with strong verbal and written communication skills. Good Collaboration skills and Team player. Key Roles and Responsibilities: •Preparation of Master Build in LIMS. •Oversee track-wise operations for QMS activities. •Preparation and review of Method Validation, Method Transfer, Method Verification, and Equivalency documents. •Preparation and review of Test Methods, STPs, and Specifications. •Operational knowledge of eDMS and ensure application compliance. •Monitor compendial changes and prepare evaluation reports (including specifications and methods) for affected site products and materials. •Review analytical data, raw data, chromatography, and LIMS for RM/PM/FP. •Prepare and review new SOPs. •Ensure timely completion of documentation. •Maintain data integrity while preparing, uploading, or reviewing documents. •Collaborate effectively across Piramal Plants. •Provide support to any PPL site as required, with role assignments based on evolving needs and timelines. •Perform activities across US, Canada, and EU time zones; available to travel for up to months to PPL sites (India and overseas) as needed. Perform additional tasks as assigned by the Leadership team based on requirements

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