BENGALURU · FULLTIME
Executive - Master Data Management
PIVOT PATH PRIVATE LIMITED
Bengaluru · onsite · Posted 62d ago
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Undisclosed1–4 yrsfulltimeBengaluru
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Section · 01
About this role
- Creation and Review of Master documents: Specification, Standard testing procedure, analysis and general procedure, raw materials and finished products in LIMS.
- Initiation and tracking of QMS events and evaluation of impact on Master documents.
- Revision of Master documents: SPEC, STPs and general procedure based on the approved change control.
- Ensuring RFT in documents by creating error free documents.
- Implementation of Pharmacopeial changes and source change document.
- Review and tracking of DMF in PLM and preparation of Master documents based on AMV/AMT/Evaluation report.
- Handling of LIMS master data activities and resolving of SAP/LIMS related queries.
- Creation and revision of Raw Data Sheet.
- Preparation of Residual solvents justification reports.
- Harmonization of SPEC/STP/RDS for API and Excipients.
- Maintaining track wise discipline by tracking pending tasks, closure of quality events.
- Ensuring compliance / completeness for applicable Logbook/Register.
- Creation of harmonized templates for Spec/STP/RDS.
- Tracking of CAPA assigned and checking on the task applicability to Master data team based on RCI.
- Implementation of previous learning / improvement points to the upcoming projects / during subsequent revision of Spec/STP/RDS.
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Section · 02
Skills
MDMAnalytical DevelopmentLIMS